Prosthetic heart valve leaflet assemblies and methods

ABSTRACT

Assembly methods for installing a leaflet assembly to an expandable frame of a prosthetic heart valve are described. The leaflet assembly comprises a plurality of leaflets coupled together at adjacent tabs, which form respective commissure tab assemblies. The commissure tab assemblies are inserted into corresponding windows of support members of the expandable frame. One or more wedge members are inserted into the commissure tab assembly, e.g., between the adjacent tabs or with the adjacent tabs therebetween, to restrain radial motion of the commissure tab assembly with respect to the window. The window can be a closed window, and the wedge member insertion can be after the commissure tab assembly is inserted into the window. Alternatively, the window can be an open window or channel, and the wedge member insertion can be before the commissure tab assembly is installed in the window.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of a PCT Patent Application No.PCT/US2021/012146, entitled “ASSEMBLY METHODS FOR A PROSTHETIC HEARTVALVE LEAFLET,” filed Jan. 5, 2021, which claims the benefit of U.S.Provisional Application No. 62/959,723, entitled “PROSTHETIC HEART VALVELEAFLET ASSEMBLIES AND METHODS,” filed Jan. 10, 2020, all of which areincorporated by reference herein in their entirety.

FIELD

The present disclosure relates to prosthetic heart valves, inparticular, to methods and assemblies for forming and installing leafletassemblies to frames of such prosthetic heart valves.

BACKGROUND

The human heart can suffer from various valvular diseases. Thesevalvular diseases can result in significant malfunctioning of the heartand ultimately require repair of the native valve or replacement of thenative valve with an artificial valve. There are a number of knownrepair devices (e.g., stents) and artificial valves, as well as a numberof known methods of implanting these devices and valves in humans.Percutaneous and minimally-invasive surgical approaches are used invarious procedures to deliver prosthetic medical devices to locationsinside the body that are not readily accessible by surgery or whereaccess without surgery is desirable. In one specific example, aprosthetic heart valve can be mounted in a crimped state on the distalend of a delivery device and advanced through the patient's vasculature(e.g., through a femoral artery and the aorta) until the prostheticvalve reaches the implantation site in the heart. The prosthetic valveis then expanded to its functional size, for example, by inflating aballoon on which the prosthetic valve is mounted, actuating a mechanicalactuator that applies an expansion force to the prosthetic valve, or bydeploying the prosthetic valve from a sheath of the delivery device sothat the prosthetic valve can self-expand to its functional size.Prosthetic valves that rely on a mechanical actuator for expansion canbe referred to as “mechanically expandable” prosthetic heart valves. Theactuator typically takes the form of pull cables, sutures, wires and/orshafts that are configured to transmit expansion forces from a handle ofthe delivery apparatus to the prosthetic valve.

Expandable, transcatheter heart valves can comprise an annular metalframe or stent and prosthetic leaflets mounted inside the frame. Theleaflets can be attached to commissure posts of the frame via commissuretab assemblies. Each commissure tab assembly can be preassembled byconnecting tabs of adjacent leaflets to each other and then attached bysuture to the commissure posts of the frame. However, such commissuretab assemblies may be relatively complex and time-consuming to assemble.Moreover, attachment of the commissure tab assembly to the commissurepost may be subject to undesirable wear along the numerous stitchesrequired. The stability of the mounted commissure tab assembly maydeteriorate due to displacement of the commissure tab assembly duringassembly handling, crimping, or valve expansion, for example, theassembly rotating around the commissure post or sliding axially alongthe commissure post.

SUMMARY

Described herein are embodiments of prosthetic heart valves and methodsfor assembling prosthetic heart valves. In some embodiments, a leafletassembly, which forms a valvular structure, is supported by anexpandable annular frame of the prosthetic heart valve. The leafletassembly comprises a plurality of leaflets coupled together at adjacenttabs, which form respective commissure tab assemblies. These commissuretab assemblies can be inserted into corresponding commissure windows ofsupport members of the annular frame in order to couple the leafletassembly to the frame. One or more wedge members can be inserted intothe commissure tab assembly, between the adjacent tabs or with theadjacent tabs therebetween, to restrain radial motion of the commissuretab assembly with respect to the commissure window. In some embodiments,the commissure window is a closed window (e.g., having openings onlyfacing a radial direction of the annular frame), and the wedge memberinsertion is after the commissure tab assembly is inserted into thecommissure window. In other embodiments, the commissure window is anopen window or channel (e.g., having an opening that faces an axialdirection of the annular frame), and the wedge member insertion isbefore the commissure tab assembly is inserted into the commissurewindow. Embodiments of the disclosed subject matter may thus offersimple and cost-effective methods for reliably mounting the leafletassembly to the heart valve while avoiding stitching sutures (or atleast reducing the impact thereof) through dynamic portions of theleaflets, thereby reducing the risk of leaflet tearing.

Any of the various innovations of this disclosure can be used incombination or separately. This summary is provided to introduce aselection of concepts in a simplified form that are further describedbelow in the detailed description. This summary is not intended toidentify key features or essential features of the claimed subjectmatter, nor is it intended to be used to limit the scope of the claimedsubject matter. The foregoing and other objects, features, andadvantages of the disclosed technology will become more apparent fromthe following detailed description, which proceeds with reference to theaccompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B are perspective views of exemplary mechanically-expandableprosthetic heart valves, according to one or more embodiments of thedisclosed subject matter.

FIG. 2 is a detail view of an actuator and an interior side of the frameof the prosthetic heart valve of FIG. 1A.

FIG. 3 is a plan view of an individual leaflet that can be used to forma leaflet assembly for a prosthetic heart valve, according to one ormore embodiments of the disclosed subject matter.

FIG. 4 is a magnified detail view showing an exemplary attachment of acommissure assembly to the frame of the prosthetic heart valve of FIG.1A, according to one or more embodiments of the disclosed subjectmatter.

FIG. 5A is a perspective view of a first example for assembling acommissure tab assembly to a closed window of a support.

FIGS. 5B-5D are top down views illustrating sequential stages inassembling the commissure tab assembly to the closed window of thesupport member, according to the first example.

FIGS. 6A-6H are various views illustrating sequential stages inassembling a commissure tab assembly to a closed window of a supportmember, according to a second example.

FIGS. 7A-7C are top down views illustrating sequential stages inassembling a commissure tab assembly to a closed window of a supportmember, according to a third example.

FIGS. 8A-8D are various views illustrating sequential stages inassembling a commissure tab assembly to a closed window of a supportmember, according to a fourth example.

FIGS. 9A-9B are top down and cross-sectional side views, respectively,of a first stage in assembling a commissure tab assembly to a taperedclosed window of a support member, according to a fifth example.

FIGS. 9C and 9D-9E are cross-sectional side and top down views,respectively, of a second stage in assembling the commissure tabassembly to the tapered closed window of the support member, accordingto the fifth example.

FIGS. 10A-10B are top down and cross-sectional side views, respectively,of a first stage in assembling a commissure tab assembly to a taperedclosed window of a support member, according to a sixth example.

FIGS. 10C-10D are cross-sectional side and top down views, respectively,of a second stage in assembling the commissure tab assembly to thetapered closed window of the support member, according to the sixthexample.

FIG. 11 is a perspective view of an exemplary support member having anopen window, according to one or more embodiments of the disclosedsubject matter.

FIGS. 12A-12D are various views illustrating sequential stages inassembling a commissure tab assembly to an open window of a supportmember, according to a seventh example.

FIGS. 13A-13D are various views illustrating sequential stages inassembling a commissure tab assembly to an open window of a supportmember, according to an eighth example.

FIGS. 14A-14D are various views illustrating sequential stages inassembling a commissure tab assembly to an open window of a supportmember, according to a ninth example.

FIG. 14E is a top-down view illustrating a first variation of the ninthexample with respect to positioning of a coupling member of thecommissure tab assembly.

FIG. 14F is a top-down view illustrating a second variation of the ninthexample with respect to positioning of a coupling member of thecommissure tab assembly.

FIGS. 15A-15C are various views illustrating sequential stages inassembling a commissure tab assembly to an open window of a supportmember, according to a tenth example.

FIGS. 16A-16C are various views illustrating sequential stages inassembling a commissure tab assembly to an open window of a supportmember, according to an eleventh example.

FIGS. 17A-17E are various views illustrating sequential stages inassembling a commissure tab assembly to an open window of a supportmember, according to a twelfth example.

FIGS. 18A-18D are various views illustrating sequential stages inassembling a commissure tab assembly to an open window of a supportmember, according to a thirteenth example.

FIGS. 19A-19D are various views illustrating sequential stages inassembling a commissure tab assembly to an open window of a supportmember, according to a fourteenth example.

FIGS. 20A, 20B, and 20D are rear perspective, side, and front views,respectively of an open commissure window formed using a wireform on asupport member, according to one or more embodiments of the disclosedsubject matter.

FIG. 20C is a rear perspective view of the support member correspondingto FIG. 20A but without the wireform installed.

FIG. 20E is a top plan view illustrating a commissure tab assemblyinstalled in the commissure window formed using the wireform of FIG.20D.

FIG. 21A shows an exemplary prosthetic valve delivery apparatus that canbe used for implanting the prosthetic heart valve of FIG. 1A, accordingto one or more embodiments of the disclosed subject matter.

FIG. 21B shows a perspective view of the distal end portion of thedelivery apparatus of FIG. 21A with the prosthetic valve of FIG. 1A in aradially-expanded state.

FIG. 22 shows another exemplary prosthetic valve delivery apparatus thatcan be used for implanting the prosthetic heart valve of FIG. 1A,according to one or more embodiments of the disclosed subject matter.

DETAILED DESCRIPTION

Described herein are examples of prosthetic heart valves, annular frameswith commissure support posts and leaflet assemblies for prostheticheart valves, and methods for assembling leaflet assemblies tocommissure support posts of annular frames to form prosthetic heartvalves. A leaflet assembly, which forms a valvular structure, issupported by an expandable annular frame of the prosthetic heart valve.The leaflet assembly comprises a plurality of leaflets coupled togetherat adjacent tabs, which form respective commissure tab assemblies. Thesecommissure tab assemblies can be inserted into corresponding commissurewindows of support members of the annular frame in order to couple theleaflet assembly to the frame. One or more wedge members can be insertedinto the commissure tab assembly, between the adjacent tabs or with theadjacent tabs therebetween, to restrain radial motion of the commissuretab assembly with respect to the commissure window. In some embodiments,the commissure window is a closed window (e.g., having openings onlyfacing a radial direction of the annular frame), and the wedge memberinsertion is after the commissure tab assembly is inserted into thecommissure window. In other embodiments, the commissure window is anopen window or channel (e.g., having an opening that faces an axialdirection of the annular frame), and the wedge member insertion isbefore the commissure tab assembly is inserted into the commissurewindow. As a result, a position of the leaflet assembly for a prostheticheart valve may be effectively locked in place during assembly and useof the prosthetic heart valve, and a time and effort for securing theleaflet assembly to the frame of the prosthetic heart valve may bereduced.

FIG. 1A shows an exemplary prosthetic heart valve 100, according to oneor more embodiments of the disclosed subject matter. The prostheticheart valve 100 can be radially compressible and expandable between aradially compressed configuration for delivery into a patient and aradially expanded configuration (as shown in FIG. 1A). In particularembodiments, the prosthetic heart valve 100 can be implanted within thenative aortic annulus, although it also can be implanted at otherlocations in the heart, including within the native mitral valve, thenative pulmonary valve, or the native tricuspid valve.

The prosthetic heart valve 100 can include an annular stent or frame102. The prosthetic valve 100 also includes one or more actuators 104for expanding/compressing the frame 102 and a valvular structure 106configured for allowing blood flow through the frame 102 in onedirection. The frame 102 can have a first axial end and a second axialend. In the depicted embodiment, the first axial end (e.g., wherevalvular structure 106 attaches to actuators 104) can be an inflow end,and the second axial end (e.g., opposite actuators 104) can be anoutflow end. The outflow end can be coupled to a delivery apparatus fordelivering and implanting the prosthetic heart valve 100 within thenative aortic valve is a transfemoral, retrograde delivery approach.Thus, in the delivery configuration of the prosthetic heart valve, theoutflow end is the proximal-most end of the prosthetic valve. In otherembodiments, the inflow end can be coupled to the delivery apparatus,depending on the particular native valve being replaced and the deliverytechnique that is used (e.g., trans-septal, transapical, etc.). Forexample, the inflow end can be coupled to the delivery apparatus (andtherefore would be the proximal-most end of the prosthetic heart valvein the delivery configuration) when delivering the prosthetic heartvalve to the native mitral valve via a trans-septal delivery approach.

The valvular structure 106 can be configured to regulate the flow ofblood through the prosthetic heart valve 100 from the inflow end to theoutflow end. The valvular structure 106 can include, for example, aleaflet assembly formed by one or more leaflets (three leafletsillustrated in FIG. 1A) made of a flexible material. As shown in FIG. 3,each leaflet 130 can comprise a main, cusp edge portion 134, two leaflettabs (also referred to herein as commissure tabs) 132 at opposing endsof the cusp edge portion 134, and an upper edge portion 136. The cuspedge portion 134, leaflet tabs 132, and upper edge portion 136 may bearranged around an outer perimeter of the leaflet 130, with the upperedge portion 136 extending between the two leaflet tabs 132 at an upperedge of the leaflet 22 and the cusp edge portion 134 extending betweenthe two leaflet tabs 132 at a lower edge of the leaflet 130. As usedhere, “upper” and “lower” may be relative to a central longitudinal axisof the prosthetic heart valve 100 when the leaflet assembly is installedand coupled to frame 102 of the prosthetic heart valve 100.

In some embodiments, the cusp edge portion 134 has a curved, scallopedshape (as shown in FIG. 3). Thus, the cusp edge portion 134 may curvebetween the two leaflet tabs 132. FIG. 3 further illustrates acenterline 138 for each of the individual leaflets 130, which may alsobe a centerline of the leaflet assembly. For example, when assembled,the centerlines 138 for each of the leaflets 130 may overlap. Further,as shown in FIG. 3, the leaflet tabs 132 may be arranged at opposingends of the cusp edge portion 134, across the centerline 138 from oneanother. In some embodiments, the leaflets and/or components of theleaflet assembly may have symmetry with respect to the centerline 138.

The leaflets 130 of the leaflet assembly can be made from in whole orpart, biological material, bio-compatible synthetic materials, or othersuch materials. Suitable biological material can include, for example,bovine pericardium (or pericardium from other sources). Further detailsregarding transcatheter prosthetic heart valves, including the manner inwhich the valvular structure can be coupled to the frame 102 of theprosthetic heart valve 100, can be found, for example, in U.S. Pat. Nos.6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202, and U.S.Patent Application Publication No. 2018/0325665, all of which areincorporated herein by reference in their entireties.

The prosthetic heart valve 100 can also include one or more skirts orsealing members. For example, the prosthetic heart valve 100 can includean inner skirt mounted on the inner surface of the frame 102 (e.g.,similar to inner skirt 20 in the exemplary valve 100 b of FIG. 1B)and/or an outer skirt mounted on the outer surface of the frame 102 (notshown in FIGS. 1A-1B). The inner skirt 20 can be a circumferential innerskirt that spans an entire circumference of the inner surface of theframe 102. The inner skirt 20 can function as a sealing member toprevent or decrease perivalvular leakage (e.g., when the valve is placedat the implantation site) and as an attachment surface to anchor aportion of the leaflets 130 to the frame 102. In particular embodiments,the cusp edge portions 134 of the leaflets can be sutured to the innerskirt 20, which in turn can be sutured to selected struts of the frame.Besides provision of inner skirt 20 and a different configuration foractuators 104 b, the prosthetic heart valve 100 b of FIG. 1B can besubstantially similar to prosthetic heart valve 100 of FIG. 1A.

The outer skirt can function as a sealing member by sealing against thetissue of the native valve annulus and helping to reduce paravalvularleakage past the prosthetic valve 100. The inner and outer skirts can beformed from any of various suitable biocompatible materials, includingany of various synthetic materials (e.g., PET) or natural tissue (e.g.,pericardial tissue). The inner and outer skirts can be mounted to theframe using sutures, an adhesive, welding, and/or other means forattaching the skirts to the frame. Further details regarding the innerand outer skirts and techniques for assembling the leaflets to the innerskirt and assembling the skirts on the frame are disclosed in U.S.Patent Application Publication No. 2019/0192296 and InternationalPublication Nos. WO/2020/159783 and WO/2020/198273, each of which isincorporated herein by reference.

As shown in FIG. 1A, frame 102 can include a plurality of interconnectedstruts arranged in a lattice-type pattern. The struts are shown aspositioned diagonally, or offset at an angle relative to, and radiallyoffset from, a longitudinal axis of the prosthetic heart valve 100 whenthe prosthetic heart valve 100 is in the expanded configuration. Inother implementations, the struts can be offset by a different amountthan depicted in FIG. 1A, or some or all of the struts can be positionedparallel to the longitudinal axis of the prosthetic heart valve 100. Inthe embodiment illustrated in FIG. 1A, the struts are pivotably coupledto one another at one or more pivot joints along the length of eachstrut. For example, each of the struts can be formed with apertures atopposing ends of the strut and apertures spaced along the length of thestrut. Respective hinges can be formed at the locations where strutsoverlap each other via fasteners or pivot members, such as rivets orpins that extend through the apertures. The hinges can allow the strutsto pivot relative to one another as the frame 102 is radially expandedor compressed, such as during assembly, preparation, or implantation ofthe prosthetic heart valve 100.

In some embodiments, the frame 102, or components thereof (e.g., strutsand/or fasteners), can be made of any of various suitableplastically-expandable materials (e.g., stainless steel, etc.) orself-expanding materials (e.g., nickel titanium alloy (NiTi), such asNitinol), as known in the art. In such configurations, Suitableplastically-expandable materials that can be used to form the frame 102include, without limitation, stainless steel, biocompatiblehigh-strength alloys (e.g., a cobalt-chromium or anickel-cobalt-chromium alloys), polymers, or combinations thereof. Inparticular embodiments, frame 102 is made of anickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPSTechnologies, Jenkintown, Pa.), which is equivalent to UNS R30035 alloy(covered by ASTM F562-02). MP35N® alloy/UNS R30035 alloy comprises 35%nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. Whenconstructed of a plastically-expandable material, the frame 102 (andthus the prosthetic valve 100) can be crimped to a radially collapsedconfiguration on a delivery catheter and then expanded inside a patientby an inflatable balloon or equivalent expansion mechanism. Details ofexemplary delivery apparatuses that can be used to deliver and implantplastically-expandable prosthetic valves are disclosed in U.S. Pat. Nos.9,339,384, 10,076,638, and 10,588,744, all of which are incorporatedherein by reference. When constructed of a self-expandable material, theframe 102 (and thus the prosthetic valve 100) can be crimped to aradially collapsed configuration and restrained in the collapsedconfiguration by insertion into a sheath or equivalent mechanism of adelivery catheter. Once inside the body, the prosthetic valve can beadvanced from the delivery sheath, which allows the prosthetic valve toexpand to its functional size. Details of exemplary delivery apparatusesthat can be used to deliver and implant self-expandable prostheticvalves are disclosed in U.S. Pat. Nos. 8,652,202 and 9,867,700, both ofwhich are incorporated herein by reference.

In some embodiments, the frame 102 can be constructed by formingindividual components (e.g., the struts and fasteners of the frame) andthen mechanically assembling and connecting the individual componentstogether. In other embodiments, the struts are not coupled to each otherwith respective hinges but are otherwise pivotable or bendable relativeto each other to permit radial expansion and contraction of the frame102. For example, the frame 102 can be formed (e.g., via laser cutting,electroforming or physical vapor deposition) from a single piece ofmaterial (e.g., a metal tube). Further details regarding theconstruction of the frame 102 and the prosthetic heart valve 100 aredescribed in U.S. Pat. Nos. 10,603,165 and 10,806,573, U.S. PatentApplication Publication Nos. 2018/0344456 and 2020/0188099, andInternational Publication No. WO/2020/081893, each of which isincorporated herein by reference.

The plurality of actuators 104 can be mounted to and disposed around aninner surface of the frame 102. The actuators 104 can be configured toapply corresponding expansion and compression forces to the frame inorder to radially expand or compress the prosthetic valve. For example,the actuators 104 can be linear actuators, each of which comprises aninner member or piston and an outer member or cylinder. The inner memberis pivotably coupled to a junction of the frame 102, such as at thefirst axial end, while the outer member is pivotably coupled to anotherjunction of the frame closer to the second axial end. Moving the innermember proximally relative to the outer member and/or moving the outermember distally relative to the inner member can be effective toradially expand the prosthetic valve 100. Conversely, moving the innermember distally relative to the outer member and/or moving the outermember proximally relative to the inner member can be effective toradially compress the prosthetic valve 100. The actuators 104 caninclude locking mechanisms that are configured to retain the prostheticvalve in an expanded state inside the patient's body. In alternativeembodiments, the actuators can be screw type actuators that comprise,for example, a rotatable inner member coupled to an outer member via oneor more threads. Rotation of the inner member relative to the outermember produces relative axial movement between the inner and outermembers and corresponding radial expansion or compression of the frame.

In some embodiments, each of the actuators 104 can be configured to forma releasable connection with one or more respective actuators of adelivery apparatus of a transcatheter delivery system. The actuators ofthe delivery apparatus can transmit forces from a handle of the deliveryapparatus to the actuators 104 for expanding or compressing theprosthetic valve. Further details of the actuators, locking mechanismsand delivery apparatuses for actuating the actuators can be found inU.S. Pat. Nos. 10,603,165 and 10,806,573, and U.S. Patent ApplicationPublication No. 2018/0325665, each of which is incorporated herein byreference. Any of the actuators and locking mechanisms disclosed in thepreviously filed patents/applications can be incorporated in any of theprosthetic valves disclosed herein. Further, any of the deliveryapparatuses disclosed in the previously filed patents/applications canbe used to deliver and implant any of the prosthetic valves disclosesherein.

For example, referring to FIGS. 21A-21B, a delivery apparatus 1500 thatcan be used to deliver and implant a prosthetic heart valve, such asprosthetic heart valve 100 or prosthetic heart valve 100 b, in the heartof a patient. The delivery apparatus 1500 can have a handle 1510, anouter elongated shaft 1520 (also referred to as a catheter) extendingdistally from the handle 1510, an input torque shaft 1524 extendingdistally from the handle 1510 through the outer shaft 1520, a gearmechanism 1530 (e.g., a gearbox) operatively connected to a distal endportion of the input torque shaft 1524, a plurality of output torqueshafts 1540, and a nose cone 1550. The nose cone 1550 can be mounted onthe distal end portion of an innermost shaft 1552 that serves as aguidewire lumen, which can extend coaxially through the input torqueshaft 1524 and can have a proximal end portion coupled to the handle1510.

A guidewire can extend through the guidewire lumen, and a distal end ofthe delivery apparatus can be advanced over the guidewire to the implantlocation. Each output torque shaft 1540 can have a proximal end portionconnected to the gear mechanism 1530 and a distal end portion releasablyconnected to a respective screw of actuator 104. Each output torqueshaft 1540 can have, for example, a rod, a rigid tube, a cable, a lasercut tube, a hypotube, or any other elongated annular structure (e.g.,any tubular or cylindrical structure). A proximal end portion of theinput torque shaft 1524 can be operatively connected to an actuator,such as a motor 1512, housed within or coupled to the handle 1510. Themotor 1512 can be, for example, an electric motor powered by batteries,which can also be housed within the handle 1510. Alternatively, themotor 1512 can be a hydraulically-driven or a pneumatically-drivenmotor. The motor 1512 can be operable to actuate or rotate the inputtorque shaft 1524, which in turn actuates or rotates the output torqueshafts 1540 via the gear mechanism 1530, which in turn actuates theprosthetic heart valve to radially expand or compress. Further detailsregarding construction and operation of a delivery apparatus fordelivering and implanting a prosthetic heart valve can be found in U.S.Pat. Nos. 9,827,093, 10,076,638, and 10,806,573, all of which areincorporated herein by reference.

FIG. 22 illustrates another exemplary delivery apparatus 1600 adapted todeliver a prosthetic heart valve, such as prosthetic heart valve 100 or100 b described herein. The prosthetic valve 100 can be releasablycoupled to the delivery apparatus 1600, such as via a removable couplingbetween a distal member of an expansion and locking mechanism of theprosthetic valve 100 and a second actuation member of an actuationassembly of the delivery apparatus 1600. The prosthetic valve 100 caninclude a distal end 103 and a proximal end 105, wherein the proximalend 105 is positioned closer to a handle 1604 of the delivery apparatus1600 than the distal end 103, and wherein the distal end 103 ispositioned farther from the handle 1604 than the proximal end 105. Itshould be understood that the delivery apparatus 1600 and other deliveryapparatuses disclosed herein can be used to implant prosthetic devicesother than prosthetic valves, such as stents or grafts.

The delivery apparatus 1600 in the illustrated embodiment generallyincludes the handle 1604, a first elongated shaft 1606 (which comprisesan outer shaft in the illustrated embodiment) extending distally fromthe handle 1604, at least one actuator assembly 1608 extending distallythrough the outer shaft 1606. In some embodiments, a distal end portion1616 of the shaft 1606 can be sized to house the prosthetic valve in itsradially compressed, delivery state during delivery of the prostheticvalve through the patient's vasculature. In this manner, the distal endportion 1616 functions as a delivery sheath or capsule for theprosthetic valve during delivery.

The at least one actuator assembly 1608 can be configured to radiallyexpand and/or radially collapse the prosthetic valve 100 when actuated,and may be removably coupled to the prosthetic heart valve 100. Althoughthe illustrated embodiment shows two actuator assemblies 1608 forpurposes of illustration, it should be understood that one actuator 1608can be provided for each actuator of the prosthetic valve. For example,three actuator assemblies 1608 can be provided for a prosthetic valvehaving three actuators. In other embodiments, a greater or fewer numberof actuator assemblies can be present. The actuator assemblies 1608 canbe releasably coupled to the prosthetic valve 100. For example, in theillustrated embodiment, each actuator assembly 1608 can be coupled to arespective actuator of the prosthetic valve 100. Each actuator assembly1608 can comprise a support tube or sleeve and an actuator member. Insome embodiments, the actuator assembly 1608 also can include a lockingtool. When actuated, the actuator assembly can transmit pushing and/orpulling forces to portions of the prosthetic valve to radially expandand collapse the prosthetic valve. The actuator assemblies 1608 can beat least partially disposed radially within, and extend axially through,one or more lumens of the outer shaft 1606. For example, the actuatorassemblies 1608 can extend through a central lumen of the shaft 1606 orthrough separate respective lumens formed in the shaft 1606.

The handle 1604 of the delivery apparatus 1600 can include one or morecontrol mechanisms (e.g., knobs or other actuating mechanisms) forcontrolling different components of the delivery apparatus 1600 in orderto expand and/or deploy the prosthetic valve 100. For example, in theillustrated embodiment the handle 1604 comprises first, second, andthird knobs 1610, 1612, and 1614. The first knob 1610 can be a rotatableknob configured to produce axial movement of the outer shaft 1606relative to the prosthetic valve 100 in the distal and/or proximaldirections in order to deploy the prosthetic valve from the deliverysheath 1616 once the prosthetic valve has been advanced to a location ator adjacent the desired implantation location with the patient's body.For example, rotation of the first knob 1610 in a first direction (e.g.,clockwise) can retract the sheath 1616 proximally relative to theprosthetic valve 100 and rotation of the first knob 1610 in a seconddirection (e.g., counter-clockwise) can advance the sheath 1616distally. In other embodiments, the first knob 1610 can be actuated bysliding or moving the knob 1610 axially, such as pulling and/or pushingthe knob. In other embodiments, actuation of the first knob 1610(rotation or sliding movement of the knob 1610) can produce axialmovement of the actuator assemblies 1608 (and therefore the prostheticvalve 100) relative to the delivery sheath 1616 to advance theprosthetic valve distally from the sheath 1616.

The second knob 1612 can be a rotatable knob configured to produceradial expansion and/or contraction of the prosthetic valve 100. Forexample, rotation of the second knob 1612 can move the actuator memberand the support tube axially relative to one another. Rotation of thesecond knob 1612 in a first direction (e.g., clockwise) can radiallyexpand the prosthetic valve 100 and rotation of the second knob 1612 ina second direction (e.g., counter-clockwise) can radially collapse theprosthetic valve 100. In other embodiments, the second knob 1612 can beactuated by sliding or moving the knob 1612 axially, such as pullingand/or pushing the knob. The third knob 1614 can be a rotatable knobconfigured to retain the prosthetic heart valve 100 in its expandedconfiguration. For example, the third knob 1614 can be operativelyconnected to a proximal end portion of the locking tool of each actuatorassembly 1608. Rotation of the third knob in a first direction (e.g.,clockwise) can rotate each locking tool to advance the locking nuts totheir distal positions to resist radial compression of the frame of theprosthetic valve. Rotation of the knob 1614 in the opposite direction(e.g., counterclockwise) can rotate each locking tool in the oppositedirection to decouple each locking tool from the prosthetic valve 100.In other embodiments, the third knob 1614 can be actuated by sliding ormoving the third knob 1614 axially, such as pulling and/or pushing theknob. Although not shown, in some embodiments, the handle 1604 caninclude a fourth rotatable knob operative connected to a proximal endportion of each actuator member. The fourth knob can be configured torotate each actuator member, upon rotation of the knob, to unscrew eachactuator member from the proximal portion of a respective actuator. Oncethe locking tools and the actuator members are uncoupled from theprosthetic valve 100, they can be removed from the patient.

The tabs 132 of adjacent leaflets 130 can be arranged together to formcommissures 112 (also referred to herein as commissure tab assemblies)that can be coupled to respective commissure support posts, therebysecuring at least a portion of the leaflet assembly to the frame 102. Insome embodiments, each of the actuators 104 can be used to support arespective commissure 112 (described below). As such, the actuators 104can include commissure support posts (also referred to herein ascommissure post or support member) for supporting and securingcommissures 112 of the valvular structure 106 to the frame 102. In someembodiments, the proximal support members 108 of the actuators 104comprise windows 110 configured to receive commissures 112 of thevalvular structure 106, as shown in FIGS. 2 and 4. Alternatively oradditionally, the frame 102 of the heart valve 100 can includecommissure support posts as separate structures from the actuators 104.For example, the commissures 112 can be mounted to support members thatare support struts or posts of the frame 102 that are separate from theactuators 104. In some embodiments, the commissure support posts (or asubsection thereof to which the commissures 112 are coupled) may besubstantially aligned with, or extend along a direction substantiallyparallel to, the longitudinal axis of the frame 102.

As shown in FIGS. 2 and 4, a proximal support member 108 of one or moreof the actuators 104 has a window 110 configured to receive leafletcommissures 112 of the valvular structure 106. For example, one or moreof the actuators 104 of the prosthetic valve 100 can comprise a proximalsupport member 108, an intermediate support member 114, a distal supportmember 116, a locking member 118, and a locking nut 120. The supportmembers 108, 114, 116 can each have an actuation lumen 121 and a lockinglumen 123. The actuation lumens 121 can be configured for receiving anactuation shaft of a delivery apparatus. The actuation shaft can bereleasably connected to the support member 116 and an outer support tubeof the delivery apparatus can abut the upper end of the support member108 such that axial movement of the actuation shaft in a proximaldirection is effective to radially expand the frame. The locking lumens123 can be configured for receiving the locking member 118 and a lockingshaft of a delivery apparatus. The proximal support member 108 ofactuator 104 can comprise an actuation tube 122, a locking tube 124, andone or more connection portions 126 (e.g., two illustrated in FIG. 2).The actuation lumen 121 can extend axially through the actuation tube122, and the locking lumen 123 can extend axially through the lockingtube 124. The connection portions 126 can also be configured formounting the proximal support member 108 to the frame 102 (e.g., viaradially-extending support projection 202, illustrated in FIG. 5A).Further details of the actuators and delivery apparatuses for actuatingthe actuators can be found in International Application No.PCT/US2020/040318, filed Jun. 30, 2020 and U.S. Provisional ApplicationNo. 62/869,948, filed Jul. 2, 2019, each of which is incorporated hereinby reference.

The tubes 122, 124 can be spaced apart from each other, and theconnection portions 126 can be disposed at the proximal and/or distalend portions of the tubes 122, 124 and extend therebetween. The tubes122, 124 and the connection portions 126 can thus define a window 110.In particular, the tubes 122, 124 and the connections portions 126define a passage radially extending through support member 108 that isclosed at opposite axial ends, such that window 110 may be considered aclosed window. As shown in FIG. 4, the closed window 110 can beconfigured to receive the commissures 112 of the valvular structure 106.For example, the commissures 112 can be assembled and a commissure tabassembly of the commissures passed through the window 110 outward alongthe radial direction of the frame 102 in order to secure the commissure112 to the frame 102.

In some embodiments, attachment of the commissure tab assembly to therespective closed window of the support member can be achieved by awedge element inserted into the commissure tab assembly once it haspassed to the radially-outer side of the window. The wedge element canincrease a width of the tab assembly such that the tab assembly cannotpass back through the window.

For example, FIGS. 5A-5D illustrate a first exemplary method ofinstalling a commissure tab assembly 212 to a support member 208 of anactuator 204 using a wedge element 236. In alternative embodiments, thesupport member 208 need not be a component of actuator. In someembodiments, for example, a prosthetic valve can have support members208 (one for each commissure) mounted to an inner surface of the frameseparate from any actuators that the prosthetic valve may have. In otherembodiments, a prosthetic valve can have support members 208 (one foreach commissure) that are integral components of the frame, such asdisclosed in U.S. Pat. No. 9,393,110, which is incorporated herein byreference. Thus, it should be understood that any commissure assemblyand assembly method therefor disclosed herein can be use in a prostheticvalve having support members that are portions of actuators, separatecomponents from the actuators, or integral components of the frame.Further, although certain illustrated embodiments of commissureassemblies are disclosed for mechanically expandable prosthetic valves,any of the disclosed embodiments can be implemented inballoon-expandable prosthetic valves, such as disclosed in U.S. Pat. No.9,393,110, or self-expandable prosthetic valves, such as disclosed inU.S. Pat. No. 8,652,202, each of which is incorporated herein byreference.

Referring to FIG. 5A, the closed window 210 of the support member 208can be defined by first member 222, second member 224, and top andbottom connection portions 226. The first and second members 222, 224can extend along an axial direction of the frame 102, while theconnection portions 226 extend along a circumferential direction of theframe 102 to connect together the first and second members 222, 224 atopposite ends thereof. The bottom connection portion 226 can include aprojection 202 at a radially outer side of the actuator 204. Theprojection 202 can couple actuator 204 to a corresponding portion of theframe 102. In some embodiments, one or both of the first and secondmembers 222, 224 can include a respective lumen 221 (e.g., actuatorlumen or locking lumen, as described above) that extends through themember along the axial direction of the frame 102. The support member208 can have an inner side that faces radially inward to a centerline ofthe frame 102, and an outer side that faces in an opposite directiontoward the anatomy when the valve 100 is installed within a patient.

Referring to FIG. 5B, the commissure tab assembly 212 can be formed bydisposing tabs 132 a, 132 b of adjacent leaflets 130 a, 130 b together.The tabs 132 a, 132 b can then be joined together by stitching, forexample, via stitches or suture loops 230, in order to form a tail. Thesutured tail may reduce the risk of the leaflet tabs of being caughtbetween struts of the frame during valve crimping. The commissure tabassembly 212 can then be passed through a radially inner end of window210 to extend beyond a radially outer end of window 210, as shown inFIG. 5C. Once fully inserted through window 210, a wedge element 236 canbe inserted between the tabs of the commissure tab assembly 212, asshown in FIG. 5D.

For example, wedge element 236 can be conveyed axially with respect tothe frame 102 and inserted between facing surfaces of the tabs. Forexample, a needle can be used to convey the wedge element 236 betweenthe tabs. In some embodiments, suture loops 230 may be left relativelyloose prior to insertion of wedge element 236, thereby providingsufficient flexibility in spacing between tabs through which the wedgeelement 236 can extend. In such embodiments, the suture loops 230 may betightened once the wedge element 236 is in its final position betweentabs of the commissure tab assembly 212.

The wedge element 236 can be disposed along the radial direction betweenthe frame 102 and the support member 208, for example, between suture230 and the radially outer end of the window 210 along the radialdirection. The wedge element 236 can be any biocompatible material orstructure capable of being inserted between the leaflet tabs withoutcausing damage thereto (e.g., tearing or ripping) and without degradingwhen disposed in the patient. For example, the wedge element 236 can beformed from a relatively thick polymer suture or cable (e.g., a braidedsuture, such as an Ethibond suture or a monofilament suture), a piece ofcloth or fabric (which can be folded one or more times to increase itsthickness), or any other structure.

The wedge element can be sized/shaped so as to increase a width of aportion the commissure tab assembly 212 along a circumferentialdirection of the frame 102. This increased width portion of thecommissure tab assembly 212 due to the inserted wedge element 236 may begreater than a width of the radially outer end of window 210, such thatthe commissure tab assembly 212 is prevented, or at least restrained,from passing back through window 210 (e.g., radially inward toward acenterline of the frame 102) by interaction between the increased widthportion of commissure tab assembly 212 and window 210.

Installing the commissures tab assembly 212 of the leaflets 130 a, 130 bto the support member 208 in this manner can provide several advantages.For example, the configuration illustrated in FIGS. 5A-5D can allow asignificant portion of the commissure tab assembly 212 to bepre-assembled prior to attachment to the frame 102. Attachment of theassembly 212 to the frame 102 may be relatively simple, involving onlywedge element 236 insertion as opposed to suturing of the assembly 212to the support member 208 in the narrow region between support member208 and the surrounding frame 102. In some embodiments, no sutures areused to attach the commissure tab assembly to the support member 208,and in particular, there are no sutures that extend through thecommissure tab assembly and around the support member or throughopenings or slots in the support member. Moreover, in some embodiments,no sutures are used for further assembly of the commissure tab assemblyafter the commissure tab assembly is inserted through the window 210.Instead, the commissure tab assembly is fixed against movement in aradial inward direction by virtue of the wedge element sized larger thanthe width of the window 210 and fixed against movement in an axialdirection by upper and lower connecting portions 226.

In some embodiments, the commissure tab assembly can have a couplingmember, such as a flexible cloth or fabric, disposed around externalsurfaces of the leaflet tabs. The coupling member can be attached to thecommissure tab assembly prior to passing through the closed window ofthe support member. Once inserted into the closed window, a wedgeelement can be inserted into the commissure tab assembly at theradially-outer side of the window, thereby increasing a width of thecommissure tab assembly such that the tab assembly cannot pass backthrough the window. The coupling member can protect portions of theleaflets from abrasion by interaction with the support member, and mayassist in providing reliable attachment of tabs of the commissure tabassembly together.

For example, FIGS. 6A-6H illustrate a second exemplary method ofinstalling a commissure tab assembly 312 to a support member 208 using awedge element 310. Referring initially to FIG. 6A, the commissure tabassembly 312 can be formed by disposing tabs 132 a, 132 b of adjacentleaflets 130 a, 130 b together. For example, the tabs 132 a, 132 b canbe arranged flat with end surfaces facing each other. A coupling member302 (also referred to as a “reinforcing member”) can be disposed overfirst surfaces of the tabs 132 a, 132 b, as shown in FIG. 6A. The tabs132 a, 132 b and the coupling member 302 can then be joined together bystitching, for example, via first stitches or first suture loops 304.After stitching, the tabs 132 a, 132 b can be rotated or flexed towardeach other (e.g., about the facing end surfaces) to form the commissuretab assembly 312 illustrated in FIG. 6B.

The commissure tab assembly 312, with coupling member 302, can then bepassed through a radially inner end of window 210 to extend beyond aradially outer end of window 210, as shown in FIGS. 6C-6D. For example,the insertion may be such the coupling member 302 passes back throughthe window 210, with free ends 306 extending from the radially inner endof window 210, as shown in FIG. 6D. Once fully inserted through window210, a wedge element 310 can be inserted between the tabs of thecommissure tab assembly 312, as shown in FIG. 6E.

For example, wedge element 310 can be conveyed axially with respect tothe frame 102 and inserted between facing surfaces of the tabs. Forexample, a needle can be used to convey the wedge element 310 betweenthe tabs. In some embodiments, first suture loops 304 may be leftrelatively loose prior to insertion of wedge element 310, therebyproviding sufficient flexibility in spacing between tabs through whichthe wedge element 310 can extend. In such embodiments, the first sutureloops 304 may be tightened once the wedge element 310 is in its finalposition between tabs of the commissure tab assembly 312.

The wedge element 310 can be disposed along the radial direction betweenthe frame 102 and the support member 208, for example, between firstsuture 304 and the radially outer end of the window 210 along the radialdirection. The wedge element 310 can be any biocompatible material orstructure capable of being inserted between the leaflet tabs withoutcausing damage thereto (e.g., tearing or ripping) and without degradingwhen disposed in the patient. For example, the wedge element 310 can beformed from a relatively thick polymer suture or cable (e.g., polyestersuture, such as Ethibond), folded piece of cloth, or any otherstructure.

The wedge element 310 can be sized/shaped so as to increase a width,along a circumferential direction of the frame 102, for a portion thecommissure tab assembly 312. This increased width portion of thecommissure tab assembly 312 due to the inserted wedge element 310 may begreater than a width of the radially outer end of window 210, such thatthe commissure tab assembly 312 is prevented, or at least restrained,from passing back through window 210 (e.g., radially inward toward acenterline of the frame 102) by interaction between the increased widthportion of commissure tab assembly 312 and window 210.

In some embodiments, the wedge element 310 can have opposite ends 310 a,310 b along the radial direction that extend beyond a height of thecommissure tab assembly 312 once fully inserted, for example, asillustrated in FIG. 6F. As loose ends 310 a, 310 b of the wedge element310 may interfere with installation or operation of the heart valve, theloose ends 310 a, 310 b can be folded over and inserted into anotherportion of the commissure tab assembly 312. In profile, the wedgeelement 310 can be substantially C-shaped, with a top exposed portion ofthe wedge element 310 extending above the commissure tab assembly 312being substantially U-shaped and a bottom exposed portion of the wedgeelement 310 extending below the commissure tab assembly 312. Forexample, each loose end 310 a, 310 b can be bent radially outward overthe line of the first suture 304 and inserted into a portion of thecommissure tab assembly 312 between the first suture 304 and a radiallyoutermost end of the commissure tab assembly 312, as shown in FIGS.6F-6H.

In some embodiments, the loose ends 310 a, 310 b can have a thickness ordiameter less than a middle portion of wedge element 310 between theloose ends 310 a, 310 b, such that insertion of the loose ends 310 a,310 b into the commissure tab assembly 312 does not substantiallyincrease a thickness of the commissure tab assembly 312. Alternatively,the wedge element 310 can have a substantially constant thickness ordiameter along its entire length, such that insertion of the loose ends310 a, 310 b into the commissure tab assembly 312 increases thethickness of the commissure tab assembly 312 between the first suture304 and the radially outermost end of the commissure tab assembly 312 ina similar manner as insertion of the wedge element 310 in the commissuretab assembly 312 between the first suture 304 and the support member208.

Once the commissure tab assembly 312 is fully inserted through window210 and prior to or after insertion of wedge element 310, the free ends306 of the coupling member 302 that extend radially inward can bewrapped around the window frame portions of the support member 208 backtoward the radially outer side of the support member, as illustrated inFIGS. 6F-6H. In some embodiments, the free ends 306 of coupling member302 can optionally be secured, for example, by stitching the free ends306 to a radially outer end portion of the commissure tab assembly 312via one or more second sutures 324, as illustrated in FIG. 6H. Thewrapping and stitching of the coupling member 302 can further secure thecommissure tab assembly 312 to the support member 208. For example, thesecond suture 324 may extend through a width of the commissure tabassembly 312 at a location along the radial direction between a radiallyoutermost end of the commissure tab assembly 312 and the first suture304.

When the loose ends 310 a, 310 b of wedge element 310 are furtherinserted into the commissure tab assembly 312, the loose ends 310 a, 310b can be between the first suture 304 and the second suture 324 alongthe radial direction. Alternatively, the second suture 324 can passthrough loose ends 310 a, 310 b of wedge element 310 as well as the freeends 306 of coupling member 302 to secure them to the commissure tabassembly 312. Alternatively, a third suture (not shown) is separatelyused to secure the loose ends 310 a, 310 b of wedge element 310 in theirinserted position, while the second suture 324 securing the free ends306 of the coupling member is spaced radially outward from the thirdsuture.

Installing the commissures tab assembly 312 of the leaflets 130 a, 130 bto the support member 208 in this manner can provide several advantages.For example, the configuration illustrated in FIGS. 6A-6F can allow asignificant portion of the commissure tab assembly 312 to bepre-assembled prior to attachment to the frame 102. Attachment of theassembly 312 to the frame 102 may be relatively simple, involvinginsertion of wedge element 310 and securing of the coupling member oncethe commissure tab assembly 312 is inserted into the support memberwindow 210. Moreover, the coupling member 302 can serve as a protectivelayer between the leaflet tabs 132 a, 132 b and the portions of thesupport member 208 forming window 210.

In some embodiments, the coupling member can be disposed between thetabs of the commissure tab assembly as well as around the externalsurfaces of the tabs. The coupling member can be attached to thecommissure tab assembly prior to passing through the closed window ofthe support member. Once inserted into the closed window, a wedgeelement can be inserted into the commissure tab assembly, for example,between facing surfaces of the coupling member that is between the tabs.The wedge element can be inserted into the commissure tab assembly atthe radially-outer side of the window, thereby increasing a width of thecommissure tab assembly such that the tab assembly cannot pass backthrough the window. The coupling member can thus protect portions of theleaflets from abrasion by interaction with the support member as well asprotect portions of the tabs from abrasion with the wedge element.

For example, FIGS. 7A-7C illustrate a third exemplary method ofinstalling a commissure tab assembly 412 to a support member 208 using awedge element 310. The third exemplary method of FIGS. 7A-7C may besimilar in many respects to the second exemplary method of FIGS. 6A-6F.However, coupling member 302 is disposed between facing surfaces ofadjacent tabs 132 a, 132 b as well as over the external surfaces of thetabs, as illustrated in FIG. 7A. For example, the leaflet tabs 132 a,132 b can be disposed adjacent to each other and then flexed in oppositedirections to form a T-shape. The coupling member 302 can then bedisposed over the surfaces of the leaflet tabs 132, 132 b, after whichthe tabs can be straightened. The coupling member 302 can thus form afolded portion or collapsed internal pocket 402 between the tabs 132 a,132 b. The tabs 132 a, 132 b and the coupling member 302 can then bejoined together by stitching, for example, via first stitches or firstsuture loops 304, to form commissure tab assembly 412.

The commissure tab assembly 412, with coupling member 302, can then bepassed through a radially inner end of window 210 to extend beyond aradially outer end of window 210, as shown in FIGS. 7B-7C. For example,the insertion may be such the coupling member 302 passes back throughthe window 210, with free ends 306 extending from the radially inner endof window 210, as shown in FIG. 7B. Once fully inserted through window210, a wedge element 310 can be inserted into the pocket 402 formed bycoupling member 302 between the tabs of the commissure tab assembly 312,as shown in FIG. 7C.

Details regarding the wedge element 310 (e.g., method of insertion,location of insertion, material composition, handling of loose ends 310a, 310 b, etc.), wrapping and securing free ends 306 of the couplingmember 302, and/or other details of the third assembly method mayotherwise be similar to that described above for the second assemblymethod in FIGS. 6A-6F. Thus, the third assembly method may offeradvantages similar to those offered by the second assembly method.Moreover, the location of the coupling member 302 between the wedgeelement 310 and the tabs 132 a, 132 b may further protect the tabs fromdamage.

In some embodiments, the wedge element or multiple wedge elements can bedisposed outside the tabs (e.g., with the tabs therebetween along acircumferential direction of the frame) rather than between the tabs. Toallow the wedge element and commissure tab assembly to pass through theclosed window, a suture retaining the coupling member to the tabs can beleft in a loose state such that the coupling member extends beyond anend of the tabs. The wedge element can be inserted between the couplingmember and the suture at a location spaced from the end of the tabs. Thecoupling member and wedge element can then be inserted through thewindow first, followed by the tabs of the commissure tab assembly. Onceinserted into the closed window, the suture can be tightened, therebypulling the coupling member and wedge element into contact with thetabs. The wedge element can thus effectively increase a width of thecommissure tab assembly such that the tab assembly cannot pass backthrough the window. The location of the wedge element outside thecoupling member can insulate the tabs from potential damage due tointeraction with the wedge element.

For example, FIGS. 8A-8D illustrate a fourth exemplary method ofinstalling a commissure tab assembly to a support member 208 using awedge element 502. Referring initially to FIG. 8A, an initial assembly,comprised of adjacent tabs 132 a, 132 b and coupling member 302, can beformed in a manner similar to that described above with respect to FIGS.6A-6B. However, the one or more first sutures 504 that stitch thecoupling member 302 and the tabs 132 a, 132 b is left in a loose state,such that coupling member 302 can be pulled from the ends of the tabs132 a, 132 b to form a collapsible external pocket 506.

A wedge element 502 can be positioned over external surfaces of thecollapsible pocket 506 formed by the coupling member 302, between theloose sutures 504 and the coupling member 302, as illustrated in FIG.8B. For example, the wedge element 502 can be a substantially U-shapedmember with legs portions 502 a, 502 b disposed on opposite sides of thecollapsible pocket 506. For example, the wedge element 502 can be aflexible member, such as a suture, that is bent from a substantiallystraight initial configuration to the illustrated U-shape configuration.A removable positioning member 508, such as a wire loop, a suture, orother structure, can be used to insert the wedge element 502 at theappropriate position between the coupling member 302 and suture 504.Alternatively, each leg portion 502 a, 502 b may instead be a separatewedge element, in which case suture 504 may also pass through the legportions 502 a, 502 b to retain the wedge elements to the couplingmember 302 during assembly without otherwise falling off. The wedgeelement or elements 502 can be formed of any biocompatible material orstructure, for example, a relatively thick polymer suture or cable(e.g., polyester suture, such as Ethibond), folded piece of cloth, orany other structure.

The combination of wedge element 502 and coupling member 302 with pocket506 collapsed can have a maximum width (e.g., twice the thickness of thewedge element 502 and the coupling member 302) that is less than a widthof the closed window 210. The wedge element 502, with pocket 506collapsed, can thus be inserted through the window 210 first, followedby insertion of the tabs 132 a, 132 b and coupling member 302, asillustrated in FIG. 8C. For example, the insertion may be such thecoupling member 302 passes back through the window 210, with free ends306 extending from the radially inner end of window 210, as shown inFIG. 8C.

In some embodiments, the removable positioning member 508 is wrappedaround a portion of the wedge element 502 between the leg portions 502a, 502 b. Alternatively, the removable positioning member 508 can passthrough pocket 506 to wrap around the coupling member and/or wedgeelement 502. In either case, the removable positioning member 508 canassist in passing the wedge element 502, coupling member 302, and tabs132 a, 132 b from the radially inner end of window 210 to the radiallyouter end of window 210. Once insertion through the window is complete,the positioning member 508 can be removed from the assembly.

Once the tabs 132 a, 132 b are fully inserted through window 210,sutures 504 can be tightened, thereby eliminating pocket 506. Inparticular, coupling member 302 is displaced into contact with theradially outermost end of the tabs 132 a, 132 b, while wedge element 502is moved to a position along the radial direction coinciding with thetabs 132 a, 132 b, as shown in FIG. 8D. The wedge element 502 can bedisposed along the radial direction between the frame 102 and thesupport member 208, for example, between the radially outermost end ofthe tabs 132 a, 132 b and the radially outer end of the window 210. Thewedge element 502 can be sized/shaped so as to provide an effectiveincreased width along a circumferential direction for a portion of thecommissure tab assembly 510. This increased width portion of thecommissure tab assembly 510 may be greater than a width of the radiallyouter end of window 210, such that the commissure tab assembly 510 isprevented, or at least restrained, from passing back through window 210(e.g., radially inward toward a centerline of the frame 102) byinteraction between the increased width portion of commissure tabassembly 510 and window 210.

Once the commissure tab assembly 510 is inserted through window 210 andsutures 504 are tightened, the free ends 306 of the coupling member 302that extend radially inward can be wrapped around the window frameportions of the support member 208 back toward the radially outer sideof the support member, as illustrated in FIG. 8D. In some embodiments,the free ends 306 of coupling member 302 can optionally be secured, forexample, by stitching the free ends 306 to a radially outer end portionof the commissure tab assembly 510 via one or more second sutures, in amanner similar to that illustrated in FIG. 6H. The wrapping andstitching of the coupling member 302 can further secure the commissuretab assembly 510 to the support member 208. In some embodiments, thefree ends 306 may include folded over portions to which the secondsutures are attached.

Installing the commissures tab assembly 510 to the support member 208 inthis manner can provide several advantages. For example, theconfiguration illustrated in FIGS. 8A-8D can allow a significant portionof the commissure tab assembly 510 to be pre-assembled prior toattachment to the frame 102. Attachment of the assembly 510 to the frame102 may be relatively simple, involving tightening of suture 504 afterinsertion into window 210 and securing of the coupling member 302 oncethe commissure tab assembly. Moreover, the coupling member 302 can serveas a protective layer between the leaflet tabs 132 a, 132 b and theportions of the support member 208 forming window 210.

In some embodiments, one or more additional wedge elements can beprovided at a radially inner end of the closed window as well as at theradially outer end, thereby restricting radial motion of the commissuretab assembly in inward and outward directions. A coupling member can bewrapped around external surfaces of a pair of adjacent leaflet tabs andattached thereto. One or more first wedge elements can optionally bedisposed on the coupling member and attached to the coupling member andtabs to form the commissure tab assembly. The commissure tab assemblycan be inserted through the closed window of the support member untilfurther insertion is restricted by the first wedge elements. Afterinsertion, a second wedge element can be inserted into the commissuretab assembly at the radially outer side of the window, therebyincreasing a width of the commissure tab assembly such that the tabassembly cannot pass back through the window. In some embodiments, thewindow may have a height along the axial direction that tapers from theradially inner side toward the radially outer side of the window. Thefirst wedge element may thus have a length, corresponding to the heightat the radially inner side of the window, longer than that of the secondwedge element, corresponding to the height at the radially outer side ofthe window.

For example, FIGS. 9A-9E illustrate a fifth exemplary method ofinstalling a commissure tab assembly 612 to a support member 608 using afirst wedge element 310. Referring initially to FIG. 9A, an initialassembly, comprised of adjacent tabs 132 a, 132 b and coupling member302, can be formed in a manner similar to that described above withrespect to FIGS. 6A-6B. After stitching at 304 and flexing of the tabs132 a, 132 b toward each other, one or more second wedge elements 602 a,602 b can be disposed on external surfaces of the coupling member 302 ata location spaced from the ends of the tabs 132 a, 132 b. The free ends306 of the coupling member 302 can optionally be wrapped around thesecond wedge elements 602 a, 602 b. One or more second sutures 604 arepassed through the free ends 306, second wedge elements 602 a, 602 b,and tabs 132 a, 132 b to stitch together the components to form thecommissure tab assembly 612, as shown in FIG. 9A. In some embodimentswhere first suture 304 is employed, the second wedge elements 602 a, 602b and second suture 604 may optionally be omitted. In other embodimentswhere second suture 604 and second wedge elements 602 a, 602 b areemployed, first suture 304 may be omitted. However, as illustrated inFIGS. 9A-9E, it may be preferable to include first suture 304, secondsuture 604, and second wedge elements 602 a, 602 b.

For example, the second wedge element 602 can be a substantiallyU-shaped member with 602 a, 602 b being separate leg portions disposedon opposite sides of the tabs 132 a, 132 b. For example, the secondwedge element 602 can be a flexible member, such as a suture, that isbent from a substantially straight initial configuration to a U-shapedconfiguration. Alternatively, each of 602 a, 602 b may instead be aseparate wedge element. The second wedge element or elements 602 can beformed of any biocompatible material or structure, for example, arelatively thick polymer suture or cable (e.g., polyester suture, suchas Ethibond), folded piece of cloth, or any other structure.

The commissure tab assembly 612, with coupling member 302, can then bepassed through a radially inner end 610 a of window 610 to extend beyonda radially outer end 610 b of window 610 until second wedge elements 602a, 602 b (or separate leg portions of a U-shaped second wedge element)abut the radially inner end 610 a, as shown in FIGS. 9B-9E. The window610 can have a height along the axial direction of the frame that variesalong the radial direction. In particular, a height of the window 610 atthe radially inner end 610 a can be greater than a height of the window610 at the radially outer end 610 b. For example, the height at theradially inner end 610 a can be 1.5-2 times greater than the height atthe radially outer end 610 b.

Although FIGS. 9B-9C show an upper edge (e.g., proximal edge) of window610 being straight and a lower edge (e.g., distal edge) of window 610being inclined, other configurations are also possible according to oneor more contemplated embodiments. For example, the upper edge of window610 could instead be inclined with the lower edge being straight. Instill another example, both edges of window 610 may be at an angle,where the respective angles of inclination/declination may besubstantially the same as each other or different from each other.

Once fully inserted through window 610, the first wedge element 310 canbe inserted into a pocket 606 between adjacent tabs 132 a, 132 b of thecommissure tab assembly 612, as shown in FIGS. 9B-9D. Details regardingthe first wedge element 310 (e.g., method of insertion, location ofinsertion, material composition, handling of loose ends 310 a, 310 b,etc.), and/or other details of the fifth assembly method may otherwisebe similar to that described above for the second assembly method inFIGS. 6A-6F. Thus, the fifth assembly method may offer advantagessimilar to those offered by the second assembly method. Alternatively,any of the commissure tab assemblies or assembly methods described abovewith respect to FIGS. 5-8 can be used to form the commissure tabassembly and insert the first wedge element in the fifth assemblymethod.

Moreover, the use of a tapered window 610, where the radially outer end610 b has a smaller height than the radially inner end 610 a, may offeradditional advantages. For example, the tapered window 610 can enablethe use of tab portions 132 a, 132 b with a smaller height along theaxial direction, which may reduce materials costs for the leaflets,coupling member 302, and wedge element 310. The smaller tab portions canfurther simplify the assembly procedure, since shorter suture lines canbe used to attach the tabs 132 a, 132 b to coupling member 302.

The tapered window 610 in combination with the second wedge element 602may also improve the durability of leaflets 130. For example, the secondwedge element 602 can insulate the portions of the commissure tabassembly 612 within window 610 from motion of the leaflets 130 duringvalve operation, thus creating an immobile area within the window 610,which can reduce the risk of damage or abrasion due to impact of thetabs with the support member 608.

Moreover, the longer stitching offered by second suture 604 at theradially inner end 610 a of the window can better distribute forces frommotion of leaflets 130 during operation to further improve durability.Indeed, in some embodiments, this distribution of forces can allow thesize of the leaflet tabs 132 a, 132 b to be further reduced. Forexample, the leaflet tabs 132 a, 132 b may terminate at or just beyond aradial location where the second wedge element 602 a, 602 b is disposed,such that the leaflet tabs do not extend to the radially outer end 610 bof the window 610.

For example, FIGS. 10A-10D illustrate a sixth exemplary method ofinstalling a commissure tab assembly to a support member 608 using afirst wedge element 310. The sixth assembly method is substantiallysimilar to the fifth method illustrated in FIGS. 9A-9E, but the couplingmember 302 extends beyond the ends of the leaflet tabs 132 a, 132 b toform an internal pocket 616, as illustrated in FIG. 10A. One or moresecond wedge elements 602 a, 602 b are disposed on external surfaces ofthe coupling member at region near the ends of the tabs 132 a, 132. Thefree ends 306 of the coupling member 302 can optionally be wrappedaround the second wedge elements 602 a, 602 b. One or more secondsutures 604 are passed through the free ends 306, second wedge elements602 a, 602 b, and tabs 132 a, 132 b to stitch together the components toform the commissure tab assembly, as shown in FIG. 10A.

The coupling member 302 can then be passed through the radially innerend 610 a of window 610 to extend beyond the radially outer end 610 b ofwindow 610 until second wedge elements 602 a, 602 b (or separate legportions of a U-shaped second wedge element) abut the radially inner end610 a, as shown in FIGS. 10B-10D. In some embodiments, the insertion maybe such that the ends of the leaflet tabs 132 a, 132 b only minimally(e.g., less than 10% of the length of the window 610 along the radialdirection) enter the window 610 at the radially inner end 610 a. Inother embodiments, the insertion may be such that no portion of theleaflet tabs 132 a, 132 b enters the window 610.

Once the coupling member 302 is fully inserted through window 610, thefirst wedge element 310 can be inserted, as shown in FIGS. 10B-10D. Forexample, wedge element 310 can be conveyed axially with respect to theframe 102 and inserted into pocket 616 between facing surfaces of thecoupling member 302. For example, a needle can be used to convey thewedge element 310 into the pocket 616. The wedge element 310 can bedisposed along the radial direction between the frame 102 and thesupport member 608, for example, between an end of pocket 616 formed bycoupling member 302 and the radially outer end 610 b of the window 610along the radial direction. The wedge element 310 can be anybiocompatible material or structure capable of being inserted betweensurfaces of the coupling member without causing damage thereto (e.g.,tearing or ripping) and without degrading when disposed in the patient.For example, the wedge element 310 can be formed from a relatively thickpolymer suture or cable (e.g., polyester suture, such as Ethibond),folded piece of cloth, or any other structure.

The wedge element 310 can be sized/shaped so as to define an increasedwidth, along a circumferential direction of the frame 102, for thecoupling member pocket 616. The coupling member pocket 616 with wedgeelement 310 thus has a width greater than a width of the radially outerend 610 b of window 610, as shown in FIGS. 10C-10D. The commissure tabassembly, which is connected to the coupling member at the other end 610a of the window, is prevented, or at least restrained, from movingradially inward toward a centerline of the frame 102 due to interactionbetween the increased-width coupling member pocket 616 and window 610.The sixth assembly method may otherwise offer advantages similar tothose offered by the fifth assembly method, described above.

Although the description above has focused on support members withclosed windows, embodiments of the disclosed subject matter are notlimited thereto. Rather, support member window configurations other thanclosed windows are also possible according to one or more contemplatedembodiments. For example, FIG. 11 shows a support member 708, accordingto another embodiment. Support member 708 can be used, for example, inlieu of support member 108, support member 208, or support member 608described above. The support member 708 is configured generally similarto any of the previously described support members, but the supportmember 708 has a window 710 that is open at one axial end, rather than acompletely enclosed window 210 of support member 208. The window 710 canthus be considered an open window of the support member 708.

The support member 708 can be a proximal support member of an actuatorcan comprise an actuation tube 722, a locking tube 724, and a connectionportion 726. The tubes 722, 724 can be spaced apart from each other andthe connection portion 726 can extend between distal end portions of thetubes 722, 724. The actuation tube 722 can comprise an actuation lumen721 configured to receive an actuation shaft of a delivery apparatus.The locking tube 724 can comprise a locking lumen 719 configured toreceive a locking shaft of a delivery apparatus. The connection portion726 can be configured for mounting the proximal support member 708 to aframe of a prosthetic valve (e.g., the frame 102). The window 710 of theproximal support member 708 is defined by the tubes 722, 724, and theconnection portion 726. In FIG. 11, the window 710 is generally “U”shaped; however, in other embodiments, the window 710 can be tapered or“V” shaped or comprise any other shape capable of receiving therein acommissure tab assembly of the valve structure.

In some embodiments, attachment of the commissure tab assembly to therespective open window of the support member can be achieved by slidingthe assembly along the axial direction of the frame into the openwindow. The commissure tab assembly can include a wedge element that isdisposed on a radially outer side of the support member once slid intothe open window. The wedge element can define an increased width portionthat prevents the commissure tab assembly from passing radially inwardthrough the window.

For example, FIGS. 12A-12D illustrate a seventh exemplary method ofinstalling a commissure tab assembly to a support member 708. Referringto FIG. 12A, the commissure tab assembly can be formed by disposing tabs132 a, 132 b of adjacent leaflets 130 a, 130 b together. The tabs 132 a,132 b can be flexed in opposite directions at their ends to form aT-shape. An internal wedge element 802 can be disposed at the center ofthe T-shape. One or more external wedge elements 806 a, 806 b can bedisposed on opposite sides of the tabs 132 a, 132 b, with the internalwedge element 802 therebetween. For example, the external wedge element806 can be a substantially U-shaped member with legs portions 806 a, 806b. For example, the external wedge element 806 can be a flexible member,such as a suture, that is bent from a substantially straight initialconfiguration to a U-shaped configuration. Alternatively, each legportion 806 a, 806 b may instead be a separate wedge element. Theinternal wedge element 802 and the external wedge element 806 a, 806 bcan be formed of any biocompatible material or structure, for example, arelatively thick polymer suture or cable (e.g., polyester suture, suchas Ethibond), folded piece of cloth, or any other structure.

The wedge elements and tabs can then be joined together by stitching,for example, by passing first stitches or suture loops 808 a throughinternal wedge element 802, tab 132 a, and external wedge element 806 aand by passing second stitches or suture loops 808 b through internalwedge element 802, tab 132 b, and external wedge element 806 b. Afterstitching, the tabs 132 a, 132 b can be straightened from their bentconfiguration, thereby enclosing the internal wedge element 802 within apocket 804 between facing surfaces of the tabs 132 a, 132 b, as shown inFIG. 12B. In particular, the internal wedge element 802 is disposedalong the radial direction between an outer end of the leaflet tabs andthe remainder of the leaflets, thereby forming the commissure tabassembly with a portion having an increased width. In some embodiments,the ends of the leaflet tabs 132 a, 132 b can be further joined togetherby stitching, for example, via third stitches or suture loops 810.

As shown in FIG. 12C, the preassembled commissure tab assembly can thenbe inserted into the open window 710 of the support member 708. Forexample, the commissure tab assembly can be conveyed along the axialdirection of the annular frame from the proximal end toward the distalend. The increased width portion of the commissure tab assembly can bedisposed on a radially outer side of support member 708. Moreover, theincreased width of the commissure tab assembly portion may be greaterthan a width of the radially outer end of window 710. Alternatively oradditionally, the external wedge elements 806 a, 806 b may define partof the increased width portion of the commissure tab assembly that abutsthe radially outer side of window 710, as shown in FIG. 12D. Thus,commissure tab assembly can be prevented, or at least restrained, frompassing inward through window 710 (e.g., radially inward toward acenterline of the frame 102) by interaction between the increased widthportion of commissure tab assembly and window 710.

The commissure tab assembly can be restrained from moving axially in anupstream direction against retrograde blood flow (e.g., during diastoleif implanted at the aortic position) by the connection potion 726. Thepressure gradient from antegrade blood flow (e.g., during systole ifimplanted at the aortic position) typically is insufficient to cause anymovement of the commissure tab assembly out of the open end of thesupport member 708 in a downstream direction. In some embodiments, thefrictional engagement between the increased width portion of thecommissure tab assembly and the adjacent surfaces of the support membercan help resist axial movement of the commissure tab assembly in anupstream direction.

Installing the commissures tab assembly of the leaflets to the supportmember 708 in this manner can provide several advantages. For example,the configuration illustrated in FIGS. 12A-12D can allow all orsubstantially all of the commissure tab assembly to be pre-assembledprior to installation to the frame 102. Attachment of the assembly tothe frame 102 may be relatively simple, involving only axially slidingthe commissure tab assembly into the open window 710 (e.g., slot opentoward an axial end of the valve) of the support member 708. This can,for example, make assembling a prosthetic valve easier, improvemanufacturing throughput, and/or improve quality. In particularembodiments, the commissure tab assembly is fully assembled prior toinstallation on the frame and no sutures or other connection structuresare used for further assembling the commissure tab assembly or forconnecting the commissure tab assembly to the frame.

In some embodiments, the external wedge elements can be replaced with acoupling member, such as a flexible cloth or fabric, disposed aroundexternal surfaces of the leaflet tabs. The coupling member can beattached to the internal wedge element and the tabs prior toinstallation in the open window of the support member. Once insertedinto the open window, the coupling member may be wrapped around thesupport member and attached to the radially outer portion of thecommissure tab assembly to further secure the assembly to the supportmember. The coupling member can thus protect portions of the leafletsfrom abrasion by interaction with the support member as well as protectportions of the tabs from abrasion with the wedge element.

For example, FIGS. 13A-13D illustrate an eighth exemplary method ofinstalling a commissure tab assembly to a support member 708. The eighthexemplary method of FIGS. 13A-13D may be similar in many respects to theseventh exemplary method of FIGS. 12A-12C. However, coupling member 302is disposed between facing surfaces of adjacent tabs 132 a, 132 b aswell as over the external surfaces of the tabs. For example, the leaflettabs 132 a, 132 b can be disposed adjacent to each other and then flexedin opposite directions to form a T-shape. The coupling member 302 canthen be disposed over the surfaces of the leaflet tabs 132, 132 b. Aninternal wedge element 902 can be disposed over the coupling member 302at the center of the T-shape. The internal wedge element 902 can beformed of any biocompatible material or structure, for example, arelatively thick polymer suture or cable (e.g., polyester suture, suchas Ethibond), folded piece of cloth, or any other structure.

The wedge element 902, coupling member 302, and tabs 132 a, 132 b canthen be joined together by stitching, for example, by passing firststitches or suture loops 906 a through one portion of coupling member302, tab 132 a, and wedge element 902 and by passing second stitches orsuture loops 906 b through another portion of coupling member 302, tab132 b, and wedge element 902. After stitching, the tabs 132 a, 132 b canbe straightened from their bent configuration, thereby enclosing theinternal wedge element 902 within a pocket 904 formed by coupling member302, as shown in FIG. 13B. In particular, the internal wedge element 902is disposed along the radial direction between an outer end of theleaflet tabs and the remainder of the leaflets, thereby forming thecommissure tab assembly with a portion having an increased width. Insome embodiments, the ends of the leaflet tabs 132 a, 132 b can befurther joined together by stitching, for example, via third stitches orsuture loops 908.

As shown in FIG. 13C, the preassembled commissure tab assembly can thenbe inserted into the open window 710 of the proximal support member 708.For example, the commissure tab assembly can be conveyed along the axialdirection of the annular frame from the proximal end toward the distalend, and the insertion may be such that the coupling member 302 passesback through the window 710, with free ends 306 extending from theradially inner end of window 710, as shown in FIG. 13D.

The increased width portion of the commissure tab assembly can bedisposed on a radially outer side of support member 708. Moreover, theincreased width of the commissure tab assembly portion may be greaterthan a width of the radially outer end of window 710. Thus, commissuretab assembly can be prevented, or at least restrained, from passinginward through window 710 (e.g., radially inward toward a centerline ofthe frame 102) by interaction between the increased width portion ofcommissure tab assembly and window 710, as shown in FIG. 13D.

Once the commissure tab assembly is fully inserted into window 710, thefree ends 306 of the coupling member 302 that extend radially inward canbe wrapped around respective window frame portions 722, 724 of thesupport member back toward the radially outer side of the supportmember, as illustrated in FIG. 13D. In some embodiments, the free ends306 of coupling member 302 can optionally be secured, for example, bystitching the free ends 306 to a radially outer end portion of thecommissure tab assembly via one or more additional sutures, for example,similar to attachment of coupling member 302 via sutures 324 in FIG. 6H.In some embodiments, the stitching via third sutures 908 can be delayeduntil after inserting into window 710. The third sutures 908 can thus beused to attach the free ends 306 of the coupling member 302 as well asthe ends of the leaflet tabs 132 a, 132 b together. The wrapping andstitching of the coupling member 302 can further secure the commissuretab assembly to the support member 708.

Installing the commissures tab assembly of the leaflets to the supportmember 708 in this manner can provide several advantages. For example,the configuration illustrated in FIGS. 13A-13D can allow all orsubstantially all of the commissure tab assembly to be pre-assembledprior to installation to the frame 102. Attachment of the assembly tothe frame 102 may be relatively simple, involving only axially slidingthe commissure tab assembly into the open window 710 (e.g., slot opentoward an axial end of the valve) of the support member 708. This can,for example, make assembling a prosthetic valve easier, improvemanufacturing throughput, and/or improve quality. Moreover, the couplingmember 302 can serve as a protective layer between the leaflet tabs 132a, 132 b and the portions of the support member 708 forming window 710.

In some embodiments, the coupling member can be disposed around externalsurfaces only of the leaflet tabs rather than between the leaflet tabs.The internal wedge element can remain between the leaflet tabs. Thecoupling member can be attached to the internal wedge element and thetabs prior to installation in the open window of the support member.Once inserted into the open window, the coupling member may be wrappedaround the support member and attached to the radially outer portion ofthe commissure tab assembly to further secure the assembly to thesupport member. In alternative embodiments, free ends of the couplingmember may be otherwise attached to the commissure tab assembly withoutwrapping around the support member. The coupling member can thus protectportions of the leaflets from abrasion by interaction with the supportmember.

For example, FIGS. 14A-14D illustrate a ninth exemplary method ofinstalling a commissure tab assembly 1010 to a support member 708. Theninth exemplary method of FIGS. 14A-14D may be similar in many respectsto the eighth exemplary method of FIGS. 13A-13C. An internal wedgeelement 1002 can be disposed on a surface of one tab 132 a and anothertab 132 b can be overlaid on top, thereby providing the internal wedgeelement 1002 in an internal pocket 1004 formed between the adjacent tabs132 a, 132 b, as illustrated in FIG. 14A. The internal wedge element1002 can be formed of any biocompatible material or structure, forexample, a relatively thick polymer suture or cable (e.g., polyestersuture, such as Ethibond), folded piece of cloth, or any otherstructure.

A coupling member 302 can then be disposed over the surfaces of theleaflet tabs 132, 132 b. However, in contrast to the eighth exemplarymethod, coupling member 302 is disposed only over the external surfacesof the adjacent tabs 132 a, 132 b. The wedge element 1002, couplingmember 302, and tabs 132 a, 132 b can then be joined together bystitching, for example, via first stitches or suture loops 1006, to formthe commissure tab assembly 1010. The internal wedge element 1002 isdisposed along the radial direction between an outer end of the leaflettabs and the remainder of the leaflets, thereby forming the commissuretab assembly 1010 with a portion having an increased width. In someembodiments, the ends of the leaflet tabs 132 a, 132 b can be furtherjoined together by stitching, for example, via second stitches or sutureloops 1008.

As shown in FIG. 14C, the preassembled commissure tab assembly can thenbe inserted into the open window 710 of the proximal support member 708.For example, the commissure tab assembly 1010 can be conveyed along theaxial direction of the annular frame from the proximal end toward thedistal end, and the insertion may be such that the coupling member 302passes back through the window 710, with free ends 306 extending fromthe radially inner end of window 710, as shown in FIG. 14D.

The increased width portion of the commissure tab assembly 1010 can bedisposed on a radially outer side of support member 708. Moreover, theincreased width of the commissure tab assembly portion may be greaterthan a width of the radially outer end of window 710. Thus, commissuretab assembly 1010 can be prevented, or at least restrained, from passinginward through window 710 (e.g., radially inward toward a centerline ofthe frame 102) by interaction between the increased width portion ofcommissure tab assembly and window 710, as shown in FIG. 14D.

Once the commissure tab assembly 1010 is fully inserted into window 710,the free ends 306 of the coupling member 302 that extend radially inwardcan be wrapped around respective window frame portions 722, 724 of thesupport member back toward the radially outer side of the supportmember, as illustrated in FIG. 14D. In some embodiments, the free ends306 of coupling member 302 can optionally be secured, for example, bystitching the free ends 306 to a radially outer end portion of thecommissure tab assembly via one or more additional sutures, for example,similar to attachment of coupling member 302 via sutures 324 in FIG. 6H.In some embodiments, the stitching via second suture 1008 can be delayeduntil after inserting the commissure tab assembly 1010 into window 710.The second suture 1008 can thus be used to attach the free ends 306 ofthe coupling member 302 as well as the ends of the leaflet tabs 132 a,132 b together. The wrapping and stitching of the coupling member 302can further secure the commissure tab assembly 1010 to the supportmember 708.

In some embodiments, the free ends 306 of the coupling member 302 may bepositioned without wrapping around the support member 708. For example,each free end 306 may be folded back on itself through the window 710,such that the free end 306 extends from the radially inner side 1012 tothe radially outer side 1016 of the window 710. This may advantageouslyprovide a double thickness portion of the coupling member on each sideof the leaflet tabs 132 a, 132 b to provide further protection. However,since the free ends 306 remain unsecured, they may slide radiallyoutward during operation of the valve, as shown in FIG. 14E.

To avoid the scenario illustrated in FIG. 14E, one or more externalwedge elements 1014 can be provided between facing surfaces of thecoupling member 302 at the radially inner side 1012 of the window 710,as illustrated in FIG. 14F. External wedge element 1014 can be conveyedaxially with respect to the frame 102 and inserted into pockets formedby the folded portion of each coupling member free end 306. For example,a needle can be used to convey the wedge element 1014 between thecoupling member portions. In some embodiments, the wedge element 1014can be a substantially U-shaped member with legs portions 1014 a, 1014 bdisposed on opposite sides of the tabs 132 a, 132 b. For example, thewedge element 1014 can be a flexible member, such as a suture, that isbent from a substantially straight initial configuration to theillustrated U-shape configuration. Alternatively, each leg portion 1014a, 1014 b may instead be a separate wedge element. The wedge element orelements 1014 a, 1014 b can be formed of any biocompatible material orstructure, for example, a relatively thick polymer suture or cable(e.g., polyester suture, such as Ethibond), folded piece of cloth, orany other structure.

Installing the commissures tab assembly 1010 of the leaflets to thesupport member 708 in this manner can provide several advantages. Forexample, the configuration illustrated in FIGS. 14A-14F can allow all orat least a significant portion of the commissure tab assembly 1010 to bepre-assembled prior to installation to the frame 102. Attachment of theassembly to the frame 102 may be relatively simple, involving axiallysliding the commissure tab assembly 1010 into the open window 710 (e.g.,slot open toward an axial end of the valve) of the support member 708and optionally stitching of the coupling member or insertion of a wedgeelement into the coupling member. This can, for example, make assemblinga prosthetic valve easier, improve manufacturing throughput, and/orimprove quality. Moreover, the coupling member 302 can serve as aprotective layer between the leaflet tabs 132 a, 132 b and the portionsof the support member 708 forming window 710.

In some embodiments, the coupling member and the internal wedge elementcan be attached to each other by a suture. The internal wedge elementand coupling member can then be inserted between adjacent leaflet tabs,and the coupling member can be further wrapped around the externalsurfaces of the tabs. The ends of the tabs can be connected together byone or more additional sutures to form the commissure tab assembly. Thecommissure tab assembly can be inserted into the open window of thesupport member. Once inserted into the open window, the coupling membermay be wrapped around the support member and attached to the radiallyouter portion of the commissure tab assembly to further secure theassembly to the support member. The coupling member can thus protectportions of the leaflets from abrasion by interaction with the supportmember, as well as protect portions of the tabs from abrasion with thewedge element.

For example, FIGS. 15A-15C illustrate a tenth exemplary method ofinstalling a commissure tab assembly 1060 to a support member 708. Thetenth exemplary method of FIGS. 15A-15C may be similar in many respectsto the ninth exemplary method of FIGS. 13A-13C. However, the internalwedge element 1052 is attached only to the coupling member 302 ratherthan to the leaflet tabs 132 a, 132 b. For example, the internal wedgeelement 1052 can be disposed on a surface of the coupling member 302, asillustrated in FIG. 15A. The internal wedge element 1052 can beconnected to the coupling member 302 by stitching, for example, by oneor more first stitches or suture loops 1054. The internal wedge element902 can be formed of any biocompatible material or structure, forexample, a relatively thick polymer suture or cable (e.g., polyestersuture, such as Ethibond), folded piece of cloth, or any otherstructure.

The leaflet tabs 132 a, 132 b can be disposed adjacent to each other andthen flexed in opposite directions to form a T-shape. The combination ofcoupling member 302 and internal wedge element 1052 can then be disposedover the surfaces of the leaflet tabs 132, 132 b, with the internalwedge element 1052 at the center of the T-shape. The tabs 132 a, 132 bcan then be straightened from their bent configuration, therebyenclosing the internal wedge element 1052 within a pocket 1056 betweenthe tabs, as shown in FIG. 15B. In particular, the internal wedgeelement 1052 is disposed along the radial direction between an outer end1059 of the leaflet tabs and the remainder of the leaflets, therebyforming the commissure tab assembly 1060 with a portion having anincreased width. In some embodiments, the ends of the leaflet tabs 132a, 132 b can be further joined together by stitching, for example, viasecond stitches or suture loops 1058.

As shown in FIG. 15C, the preassembled commissure tab assembly 1060 canthen be inserted into the open window 710 of the proximal support member708. For example, the commissure tab assembly 1060 can be conveyed alongthe axial direction of the annular frame from the proximal end towardthe distal end, and the insertion may be such that the coupling member302 passes back through the window 710, with free ends 306 extendingfrom the radially inner end of window 710.

The increased width portion of the commissure tab assembly 1060 can bedisposed on a radially outer side of support member 708. Moreover, theincreased width of the commissure tab assembly portion may be greaterthan a width of the radially outer end of window 710. Thus, commissuretab assembly 1060 can be prevented, or at least restrained, from passinginward through window 710 (e.g., radially inward toward a centerline ofthe frame 102) by interaction between the increased width portion ofcommissure tab assembly and window 710. Once the commissure tab assembly1060 is fully inserted into window 710, the free ends 306 of thecoupling member 302 can be wrapped around the support member 708 (in amanner similar to that described above for FIG. 14D), passed backthrough window 710 (in a manner similar to that described above forFIGS. 14E-14F), or in any other manner.

In some embodiments, the wedge element or multiple wedge elements can bedisposed outside the tabs (e.g., with the tabs therebetween along acircumferential direction of the frame) rather than between the tabs. Acoupling member can be wrapped around external surfaces of the tabs,after which a wedge element can be disposed on opposite sides of thecoupling member. The wedge element, coupling member, and tabs can beconnected together by one or more sutures to form the commissure tabassembly. The commissure tab assembly can be inserted into the openwindow of the support member. Once inserted into the open window, thecoupling member may be wrapped around the support member and attached tothe radially outer portion of the commissure tab assembly to furthersecure the assembly to the support member. The coupling member can thusprotect portions of the leaflets from abrasion by interaction with thesupport member, as well as protect portions of the tabs from abrasionwith the wedge element.

For example, FIGS. 16A-16C illustrate an eleventh exemplary method ofinstalling a commissure tab assembly to a support member 708. Referringinitially to FIG. 16A, the commissure tab assembly can be formed bydisposing tabs 132 a, 132 b of adjacent leaflets 130 a, 130 b together.The coupling member 302 can then be disposed over the external surfacesof the leaflet tabs 132, 132 b. One or more external wedge elements 1102a, 1102 b can be disposed on opposite sides of the tabs 132 a, 132 b.For example, the external wedge element 1102 can be a substantiallyU-shaped member with legs portions 1102 a, 1102 b. For example, theexternal wedge element 1102 can be a flexible member, such as a suture,that is bent from a substantially straight initial configuration to aU-shaped configuration. Alternatively, each leg portion 1102 a, 1102 bmay instead be a separate wedge element. The external wedge element 1102a, 1102 b can be formed of any biocompatible material or structure, forexample, a relatively thick polymer suture or cable (e.g., polyestersuture, such as Ethibond), folded piece of cloth, or any otherstructure.

The external wedge element 1102 a, 1102 b and tabs 132 a, 132 b can thenbe joined together by stitching, for example, via one or more firststitches or suture loops 1104. The external wedge element 1102 a, 1102 bis disposed along the radial direction between an outer end of theleaflet tabs and the remainder of the leaflets, thereby effectivelyforming the commissure tab assembly with a portion having an increasedwidth.

As shown in FIG. 16C, the preassembled commissure tab assembly can thenbe inserted into the open window 710 of the proximal support member 708.For example, the commissure tab assembly can be conveyed along the axialdirection of the annular frame from the proximal end toward the distalend. The increased width portion of the commissure tab assembly can bedisposed on a radially outer side of support member 708. Moreover, thecombined width of the commissure tab assembly and the external wedgeelement 1102 a, 1102 b along the circumferential direction may begreater than a width of the radially outer end of window 710. Thus, thecommissure tab assembly can be prevented, or at least restrained, frompassing inward through window 710 (e.g., radially inward toward acenterline of the frame 102) by interaction between the external wedgeelement 1102 a, 1102 b and window 710. Once the commissure tab assemblyis fully inserted into window 710, the free ends 306 of the couplingmember 302 can be wrapped around the support member 708 (in a mannersimilar to that described above for FIG. 14D), passed back throughwindow 710 (in a manner similar to that described above for FIGS.14E-14F), or in any other manner.

Installing the commissures tab assembly of the leaflets to the supportmember 708 in this manner can provide several advantages. For example,the configuration illustrated in FIGS. 16A-16C can allow all orsubstantially all of the commissure tab assembly to be pre-assembledprior to installation to the frame 102. Attachment of the assembly tothe frame 102 may be relatively simple, involving only axially slidingthe commissure tab assembly into the open window 710 (e.g., slot opentoward an axial end of the valve) of the support member 708, andoptional attachment of the coupling member free ends. This can, forexample, make assembling a prosthetic valve easier, improvemanufacturing throughput, and/or improve quality.

In some embodiments, the leaflet tabs can be wrapped around an internalwedge element. Ends of the leaflet tabs can be overlapped with eachother and extending in opposite directions. The internal wedge elementcan be disposed on one of the leaflet tabs. A secondary wedge elementcan be disposed on a side of the overlapped portion of the leaflet tabsopposite from the internal wedge element. The internal wedge element andthe secondary wedge element can be coupled together by one or moresutures, and the leaflet tabs can then be wrapped around the internalwedge element to form the commissure tab assembly. The commissure tabassembly can then be inserted into the open window of a support member.

For example, FIGS. 17A-17E illustrate a twelfth exemplary method ofinstalling a commissure tab assembly 1200 to a support member 708.Referring initially to FIGS. 17A-17B, the commissure tab assembly 1200can be formed by overlapping tabs 132 a, 132 b. For example, the tabs132 a, 132 b can be arranged flat with end surfaces overlapping by alength, L, and the leaflets extending in opposite directions. Aninternal wedge element 1202 can be disposed on one side of theoverlapping section of the leaflet tabs, for example, a surface of tab132 b. For example, the internal wedge element 1202 can have athickness, D_(w), less than the length, L, of the overlap, and may bepositioned at a midpoint of the overlapped portions (e.g., L/2 fromeither end of the tabs 132 a, 132 b).

A secondary wedge element 1204 can be disposed on a side of theoverlapping section of the leaflet tabs opposite that of the internalwedge element 1202, for example, a surface of tab 132 a. For example,the secondary wedge element 1204 can have a thickness less than thethickness, D_(w), of the internal wedge element 1202. For example, theinternal wedge element 1202 and/or the secondary wedge element 1204 canbe formed from a relatively thick polymer suture or cable (e.g.,polyester suture, such as Ethibond), folded piece of cloth, or any otherstructure.

In some embodiments, the internal wedge element 1202 can have a height,H_(w), (e.g., along an axial direction of the frame when installed) thatis less than that the corresponding height, H_(L), of the overlappedportion of the leaflet tabs. For example, the wedge height, H_(w), canbe less than the tab height, H_(L), such that the proximal end portion1202 a and distal end portion 1202 b of the internal wedge element 1202are substantially covered by the leaflet tabs 132 a, 132 b once the tabsare wrapped around the internal wedge element. Such a configuration maymitigate tissue ingrowth by covering portions 1202 a, 1202 b that may besusceptible when otherwise exposed.

In some embodiments, the secondary wedge element 1204 can have a heightgreater than height, H_(L), of the overlapped portion of the leaflettabs, such that the secondary wedge element 1204 has free ends 1204 a,1204 b that extend above or below the leaflet tabs. In such embodiments,the free ends of the secondary wedge element 1204 can be placed in asecured position in an interior of the commissure tab assembly 1200. Forexample, one free end 1204 a of the secondary wedge element 1204 can beinserted into a proximal end portion 1202 a of the internal wedgeelement 1202, while the opposite free end 1204 b of the secondary wedgeelement 1204 can be inserted into a distal end portion 1202 b of theinternal wedge element 1202, as shown in FIG. 17A. For example, when theinternal wedge element 1202 is formed of a multistrand suture, the freeends 1204 a, 1204 b of the secondary wedge element may be insertedbetween strands or otherwise woven into wedge element 1202.Alternatively, the free ends 1204 a, 1204 b may be tucked into aposition 1208 adjacent to the internal wedge element 1202, as shown inFIG. 17B.

The wedge elements 1202, 1204 and the leaflet tabs 132 a, 132 b can bejoined together by stitching, for example, by passing first stitches orsuture loops 1206 therethrough, as illustrated in FIG. 17B. Afterstitching, the tabs 132 a, 132 b can be flexed toward each other to wraparound the internal wedge element 1202 and with facing surfacescontacting each other to form the commissure tab assembly illustrated inFIG. 17C. The internal wedge element 1202 is thus enclosed by thewrapped leaflet tabs 132 a, 132 b, with the secondary wedge element 1204disposed at radially outermost end of the commissure tab assembly.

The internal wedge element 1202 is disposed along the radial directionbetween an outer end of the leaflet tabs and the remainder of theleaflets, thereby forming the commissure tab assembly with a radiallyouter portion 1210 having an increased width as compared to an adjacentradially inner portion 1212. As shown in FIGS. 17D-17E, the preassembledcommissure tab assembly can then be inserted into the open window 710 ofthe proximal support member 708. For example, the commissure tabassembly can be conveyed along the axial direction of the annular framefrom the proximal end toward the distal end.

The increased width portion 1210 of the commissure tab assembly can bedisposed on a radially outer side of support member 708, with theradially inner portion 1212 being disposed within window 710. Theincreased width of the commissure tab assembly portion 1210 may begreater than a width of the radially outer end of window 710. Forexample, the thickness, D_(w), of the internal wedge element 1202combined with the width, W_(L), of each leaflet tab 132 a, 132 b can begreater than a width of window 710 along the circumferential directionof the frame (e.g., D_(w)+2×W_(L)>width of window 710). Thus, thecommissure tab assembly can be prevented, or at least restrained, frompassing inward through window 710 (e.g., radially inward toward acenterline of the frame 102) by interaction between the increased widthportion 1210 of the commissure tab assembly and window 710.

Installing the commissures tab assembly of the leaflets to the supportmember 708 in this manner can provide several advantages. For example,the configuration illustrated in FIGS. 17A-17E can allow all orsubstantially all of the commissure tab assembly to be pre-assembled ina flat configuration prior to installation to the frame 102. The use ofsecondary wedge element 1204 can also avoid the use of a couplingmember, which may simplify fabrication and/or reduce material costs.Attachment of the assembly to the frame 102 may be relatively simple,involving only axially sliding the commissure tab assembly into the openwindow 710 (e.g., slot open toward an axial end of the valve) of thesupport member 708. This can, for example, make assembling a prostheticvalve easier, improve manufacturing throughput, and/or improve quality.

In some embodiments, the leaflet tabs can be wrapped around one or moreinternal wedge elements, with the wrapped tab portions extending backthrough the support member window. The leaflet tabs can be initiallydisposed together, and wedge elements disposed outside the tabs (e.g.,with the tabs therebetween). The wedge elements and tabs can beconnected together by one or more sutures, and the leaflet tabs can bewrapped around the wedge elements to form the commissure tab assembly.The commissure tab assembly can then be inserted into the open window ofa support member.

For example, FIGS. 18A-18D illustrate a thirteenth embodiment ofinstalling a commissure tab assembly 1408 to a support member 708.Referring initially to FIGS. 18A-18B, the commissure tab assembly can beformed by disposing tabs 132 a, 132 b of adjacent leaflets 130 a, 130 btogether. One or more wedge elements 1402 a, 1402 b can be disposed onopposite sides of the tabs 132 a, 132 b. For example, the wedge element1402 can be a substantially U-shaped member with legs portions 1402 a,1402 b. For example, the wedge element 1402 can be a flexible member,such as a suture, that is bent from a substantially straight initialconfiguration to a U-shaped configuration. Alternatively, each legportion 1402 a, 1402 b may instead be a separate wedge element. Thewedge element 1402 a, 1402 b can be formed of any biocompatible materialor structure, for example, a relatively thick polymer suture or cable(e.g., polyester suture, such as Ethibond), folded piece of cloth, orany other structure.

The wedge elements 1402 a, 1402 b and tabs 132 a, 132 b can be joinedtogether by stitching, for example, via one or more first stitches 1404(e.g., suture loops). After stitching, free ends 1406 a, 1406 b of thetabs 132 a, 132 b can be rotated away from each other to wrap aroundeach respective wedge element 1402 a, 1402 b, thereby forming a pocketthat encloses each tab respectively, as shown in FIG. 18B.Alternatively, the wrapping of free ends 1406 a, 1406 b can occur priorto stitching, such that the first stitch 1404 extends through thewrapped portions of the tabs 132 a, 132 b as well as the wedge elements1402 a, 1402 b and the portions of the tabs 132 a, 132 b between thewedge elements 1402 a, 1402 b.

Each wedge element 1402 a, 1402 b is disposed along the radial directionbetween an outermost end of the commissure tab assembly and theremainder of the leaflets, thereby forming the commissure tab assemblywith a radially outer portion 1410 having an increased width as comparedto an adjacent radially inner portion 1412. Moreover, the folded backfree end 1406 a, 1406 b of the tabs can extend back along thecorresponding tab to form the radially inner portion 1412 have a widththat is four times the thickness of each leaflet tab.

As shown in FIGS. 18C-18D, the preassembled commissure tab assembly canthen be inserted into the open window 710 of the proximal support member708. For example, the commissure tab assembly can be conveyed along theaxial direction of the annular frame from the proximal end toward thedistal end. The increased width portion 1410 of the commissure tabassembly can be disposed on a radially outer side of support member 708,with the radially inner portion 1412 being disposed within window 710.The increased width of the commissure tab assembly portion 1410 may begreater than a width of the radially outer end of window 710. Forexample, the thickness, D_(w), of each wedge element 1402 a, 1402 bcombined with the width, W_(L), of each leaflet tab 132 a, 132 b can begreater than a width of window 710 along the circumferential directionof the frame (e.g., 2×D_(w)+4×W_(L)>width of window 710). Thus, thecommissure tab assembly can be prevented, or at least restrained, frompassing inward through window 710 (e.g., radially inward toward acenterline of the frame 102) by interaction between the increased widthportion 1410 of the commissure tab assembly and window 710.

Moreover, the free ends 1406 a, 1406 b as part of the radially innerportion 1412 can provide a four-layer leaflet tab structure within openwindow 710, thereby improving the reliability of the assembly. Forexample, the free ends 1406 a, 1406 b can act as anti-abrasion portionsseparating the other portions of the leaflet tabs 132 a, 132 b fromcontact with tubes 722, 724 of the support member 708. In someembodiments, the free ends 1406 a, 1406 b may disposed at a locationadjacent to a radially inner side of the window 710. For example, thewrapped ends of the leaflet tabs may be disposed so as not to extendradially inward beyond window 710, e.g., with ends 1406 a, 1406 bdisposed at a location along the radial direction between the radiallyouter side of window 710 and the radially inner side of window 710.

Installing the commissures tab assembly of the leaflets to the supportmember 708 in this manner can provide several advantages. For example,the configuration illustrated in FIGS. 18A-18D can allow all orsubstantially all of the commissure tab assembly to be pre-assembledprior to installation to the frame 102. The use of a four-layerthickness within the support member window can also avoid the use of acoupling member, which may simplify fabrication and/or reduce materialcosts. Attachment of the assembly to the frame 102 may be relativelysimple, involving only axially sliding the commissure tab assembly intothe open window 710 (e.g., slot open toward an axial end of the valve)of the support member 708. This can, for example, make assembling aprosthetic valve easier, improve manufacturing throughput, and/orimprove quality.

In some embodiments, one or more coupling members can be combined withthe wrapping of leaflet tabs around one or more internal wedge elements.For example, FIGS. 19A-19D illustrate a fourteenth embodiment ofinstalling a commissure tab assembly to a support member. Referringinitially to FIGS. 19A-19B, the commissure tab assembly can be formed bydisposing tabs 132 a, 132 b of adjacent leaflets 130 a, 130 b together.The tabs 132 a, 132 b can be flexed in opposite directions at their endsto form a T-shape. A coupling member 1422 a, 1422 b can then be disposedover a respective upper surface of T-shape formed by the leaflet tabs132 a, 132 b. Alternatively, a single coupling member can be used inplace of the pair of coupling members 1422 a, 1422 b.

One or more wedge elements 1402 a, 1402 b can be disposed on surfaces ofthe T-shape formed by tabs 132 a, 132 b opposite to the coupling members1422 a, 1422 b. For example, the wedge element 1402 can be asubstantially U-shaped member with legs portions 1402 a, 1402 b. Forexample, the wedge element 1402 can be a flexible member, such as asuture, that is bent from a substantially straight initial configurationto a U-shaped configuration. Alternatively, each leg portion 1402 a,1402 b may instead be a separate wedge element. The wedge element 1402a, 1402 b can be formed of any biocompatible material or structure, forexample, a relatively thick polymer suture or cable (e.g., polyestersuture, such as Ethibond), folded piece of cloth, or any otherstructure.

The wedge element 1402 a, coupling member 1422 a, and tabs 132 a can bejoined together by stitching, for example, via one or more firststitches or suture loops 1420 a. Similarly, the wedge element 1402 b,coupling member 1422 b, and tab 132 b can be joined together bystitching, for example, via one or more second stitches or suture loops1420 b. In some embodiments, the coupling members 1422 a, 1422 bcomprise folded end portions 1424 a, 1424 b through which the respectivesutures 1420 a, 1420 b are passed.

After stitching, free ends 1406 a, 1406 b of the tabs 132 a, 132 b canbe rotated further away from each other to wrap around each respectivewedge element 1402 a, 1402 b, thereby forming a pocket that encloseseach tab respectively, as shown in FIG. 19B. Optionally, adjacent endsof the coupling members can be further joined together by stitching, forexample, via one or more third stitches or suture loops 1426.Alternatively, the wrapping of free ends 1406 a, 1406 b can occur priorto stitching, such that a single stitch is used to join together thewrapped portions of the tabs 132 a, 132 b, the wedge elements 1402 a,1402 b, the portions of the tabs 132 a, 132 b between the wedge elements1402 a, 1402 b, and the coupling members 1422 a, 1422 b.

Each wedge element 1402 a, 1402 b is disposed along the radial directionbetween an outermost end of the commissure tab assembly and theremainder of the leaflets, thereby forming the commissure tab assemblywith a radially outer portion 1430 having an increased width as comparedto an adjacent radially inner portion 1432. Moreover, the folded backfree end 1406 a, 1406 b of the tabs can extend back along thecorresponding tab to form the radially inner portion 1432 have a widththat is four times the thickness of each leaflet tab.

As shown in FIGS. 19C-19D, the preassembled commissure tab assembly canthen be inserted into the open window 710 of the proximal support member708. For example, the commissure tab assembly can be conveyed along theaxial direction of the annular frame from the proximal end toward thedistal end. The increased width portion 1430 of the commissure tabassembly can be disposed on a radially outer side of support member 708,with the radially inner portion 1432 being disposed within window 710.Once the commissure tab assembly is fully inserted into window 710, freeends of each coupling member 1422 a, 1422 b can be wrapped around thesupport member 708 (in a manner similar to that described above for FIG.14D), passed back through window 710 (in a manner similar to thatdescribed above for FIGS. 14E-14F), or in any other manner.

The increased width of the commissure tab assembly portion 1410 may begreater than a width of the radially outer end of window 710. Forexample, the thickness, D_(w), of each wedge element 1402 a, 1402 bcombined with the thickness, t, of the coupling member 1422, and thewidth, W_(L), of each leaflet tab 132 a, 132 b can be greater than awidth of window 710 along the circumferential direction of the frame(e.g., 2×t+2×D_(w)+4×W_(L)>width of window 710). Thus, the commissuretab assembly can be prevented, or at least restrained, from passinginward through window 710 (e.g., radially inward toward a centerline ofthe frame 102) by interaction between the increased width portion 1410of the commissure tab assembly and window 710. Moreover, the free ends1406 a, 1406 b as part of the radially inner portion 1432 can provide afour-layer leaflet tab structure within open window 710, therebyimproving the reliability of the assembly. For example, the free ends1406 a, 1406 b and coupling members 1422 a, 1422 b can act asanti-abrasion portions separating the other portions of the leaflet tabs132 a, 132 b from contact with tubes 722, 724 of the support member 708.

Installing the commissures tab assembly of the leaflets to the supportmember 708 in this manner can provide several advantages. For example,the configuration illustrated in FIGS. 19A-19D can allow all orsubstantially all of the commissure tab assembly to be pre-assembledprior to installation to the frame 102. Attachment of the assembly tothe frame 102 may be relatively simple, involving only axially slidingthe commissure tab assembly into the open window 710 (e.g., slot opentoward an axial end of the valve) of the support member 708 and optionalsecuring of free ends of the coupling member. This can, for example,make assembling a prosthetic valve easier, improve manufacturingthroughput, and/or improve quality.

As noted above, any of the disclosed wedge elements (whether internal,external, or otherwise) can be formed from a relatively thick,multi-filament or monofilament suture, yarn or cable (e.g., a braided,polyester suture, such as an Ethibond suture), a piece of cloth orfabric folded one or more times to increase its thickness, or any otherstructure. For example, the disclosed wedge elements, or sutures coupledthereto, can be formed of a material that does not encourage tissueingrowth, such as ultra-high molecular weight polyethylene (UHMPE),polyethylene terephthalate (PET), polyurethane (PU), orpolytetrafluoroethylene (PTFE). Alternatively or additionally, any othermaterial that is minimally porous, configured to prevent or minimizeneo-vascularization, or does not allow tissue anchoring can be used forthe disclosed wedge elements. Alternatively or additionally, thedisclosed wedge elements can be a coated or laminated polymericmaterial. In some embodiments, the material for the disclosed wedgeelements can be a polymer material that is processed in a manner, orotherwise configured, to reduce the likelihood to tissue ingrowth. Forexample, if exposure of the material to certain levels of heat mayinduce thrombogenicity, the materials for the disclosed wedge elementsmay be processed in a manner that avoids or reduces such heating steps.

Although the description above has focused on the installation ofcommissure tab assemblies to windows formed in the support memberitself, embodiments of the disclosed subject matter are not limitedthereto. Rather, in some embodiments, the window may be formed byanother member coupled to the support member (or the actuator). Forexample, a wireform (e.g., bent piece of wire) or clamp can be attachedto the support member to form an open or closed window, into which anyof the commissure tab assemblies disclosed herein can be installed.Further details regarding wireforms, can be found, for example, inInternational Publication No. WO/2020/102487, which is incorporatedherein by reference.

For example, a wireform 1300 can be formed by bending a piece of wire(e.g., a straight piece of wire) into the shape shown in FIG. 20D andsecuring a connection portion 1352 to the free ends of the wire, such asby welding. In alternative embodiments, other techniques and/or methodscan be used to form a wireform 1300. For example, a clamp can be formedby molding (e.g., injection molding), machining (e.g., laser cutting),or 3D printing.

FIGS. 20A-20D are various views illustrating the wireform 1300 situatedon an actuator component 1328 (e.g., support member). The actuatorcomponent 1328 can be, for example, the outer member of an actuator of amechanically-expandable prosthetic heart valve, similar to the outermembers of the actuator 104 of the prosthetic valve 100 of FIG. 1A. Inthe illustrated embodiment, the actuator component 1328 can have arectangular cross-section, although in other embodiments the actuatorcomponent may have a round cross-section, or a cross-section having anyother selected shape.

Collar portions 1304, 1306 of the wireform 1300 can be shaped tocorrespond to the cross-sectional shape of the actuator component 1328taken in a plane perpendicular to the longitudinal axis 1337 of theactuator component. The wireform 1300 can be positioned on the actuatorcomponent 1328 such that the clamping members 1308 and 1310 are situatedagainst a radially inward-facing surface of the actuator component 1328,and the rear portions 1316, 1318 are disposed around a radiallyoutward-facing surface 1332 (FIG. 20A) of the actuator component.

Referring to FIG. 20C, in certain embodiments the actuator components1328 can comprise grooves or channels 1334, 1336 configured to receivethe portions 1316, 1318 of the wireform 1300. In some embodiments, theradially inward surface of the actuator component 1328 can define anaxially-extending groove or channel 1338, as shown in FIGS. 20D-20E.Together, the axially extending members 1308, 1310 and the connectingportion 1352 can form an open window 1350 into which a commissure tabassembly can be inserted, as illustrated in FIG. 20E. Further detailsregarding the construction and use of wireforms, can be found, forexample, in International Publication No. WO/2020/102487, which isincorporated herein by reference.

Although particular shapes and configurations for the support membersand windows have been illustrated in the figures and described in theexamples above, embodiments of the disclosed subject matter are notlimited thereto. Indeed, in some embodiments, the tubes forming thewindow of the support member may have a cross-sectional geometry (e.g.,in a plane perpendicular to the longitudinal axis of the annular frame)that is circular, oval, hexagonal, octagonal, or any other shape. Insome embodiments, the tubes of the support member forming the open orclosed windows may have lumens extending therethrough. In otherembodiments, the support member tubes may be substantially solidthroughout their thickness. In some embodiments, the support member maybe substantially symmetric about its centerline, such that the tubes onopposite sides of the window have a similar geometry, for example, asillustrated in FIG. 11. In other embodiments, the support member may beasymmetrical about its centerline, such that the tubes on opposite sidesof the window have a different geometry, for example, as illustrated inFIG. 6C.

Additional Description of Embodiments of Interest

Clause 1. An assembly method for a prosthetic heart valve, the methodcomprising:

disposing tabs of adjacent leaflets together, each leaflet having a pairof tabs on opposite sides with respect to a centerline thereof;

coupling together portions of the tabs of the adjacent leaflets to forma commissure tab assembly, the coupled portions being spaced from endsof the tabs;

conveying the commissure tab assembly through a closed window of asupport member of an expandable frame of the prosthetic heart valve, theconveying being along a radial direction of the expandable frame from aradially-inner side of the closed window to a radially-outer side of theclosed window; and

inserting a wedge between the tabs of the commissure tab assembly at afirst location along the radial direction between the coupled portionsand the radially-outer side of the closed window, a width along acircumferential direction of the annular frame for a portion of thecommissure tab assembly being increased by the wedge,

wherein the increased width of the commissure tab assembly portion isgreater than a width along the circumferential direction for acorresponding portion of the radially-outer side of the closed window,and

wherein movement of the commissure tab assembly inward along the radialdirection is restrained by interaction of the increased width portion ofthe commissure tab assembly with the corresponding portion of the closedwindow of the support member.

Clause 2. The method of clause 1, wherein the coupling together portionsof the tabs to form the commissure tab assembly comprises stitchingtogether the portions of the tabs using one or more first sutures.

Clause 3. The method of any one of clauses 1-2, wherein the expandableframe of the prosthetic heart valve comprises an annular frame having aninflow end and an outflow end separated from the inflow end along anaxial direction of the frame, and/or the support member is coupled tothe expandable frame.

Clause 4. The method of any one of clauses 1-3, wherein the expandableframe is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration.

Clause 5. The method of any one of clauses 1-4, wherein:

the disposing tabs of adjacent leaflets comprises providing a couplingmember over exposed surface portions of the pair of tabs of the adjacentleaflets; and

the stitching comprises stitching together the coupling member and thetabs of the adjacent leaflets via the first suture to form thecommissure tab assembly.

Clause 6. The method of any one of clauses 1-5, wherein:

the providing the coupling member is such that a portion of the couplingmember is arranged between facing surfaces of the pair of tabs so as toform a collapsed pocket portion; and

the inserting the wedge comprises expanding the pocket portion anddisposing the wedge therein.

Clause 7. The method of any one of clauses 1-6, wherein, after theconveying, free ends of the coupling member extend from theradially-inner side of the closed window, the method further comprising:

wrapping each free end around an adjacent portion of the support membertoward the radially-outer side of the closed window; and

stitching together the free ends and the commissure tab assembly via asecond suture spaced from the ends of the tabs,

wherein the first suture is between the wedge and the second suturealong the radial direction.

Clause 8. The method of any one of clauses 1-7, wherein:

after the inserting, one or more ends of the wedge extend axially aboveor below the commissure tab assembly, and

the method further comprises inserting the one or more ends of the wedgebetween the tabs of the commissure tab assembly at a second locationalong the radial direction between the first location and the ends ofthe tabs.

Clause 9. The method of any one of clauses 1-8, wherein the secondlocation is between the first suture and the second suture along theradial direction.

Clause 10. The method of any one of clauses 1-9, wherein the couplingmember comprises a cloth or fabric.

Clause 11. The method of any one of clauses 1-10, wherein each wedgecomprises a braided polymer suture or cable.

Clause 12. The method of any one of clauses 1-11, wherein each windowcomprises an opening or channel defined by a wireform coupled to thesupport member.

Clause 13. The method of any one of clauses 1-12, wherein the valvularstructure is a bicuspid structure with two leaflets and two commissuretab assemblies, and the commissure support posts are on diametricallyopposite sides of the annular frame from each other.

Clause 14. The method of any one of clauses 1-12, wherein the valvularstructure is a tricuspid structure with three leaflets and threecommissure tab assemblies, and the commissure support posts are equallyspaced around a circumference of the annular frame.

Clause 15. The method of any one of clauses 1-14, wherein the frame isformed of a plastically-expandable material or a self-expandingmaterial.

Clause 16. The method of any one of clauses 1-14, wherein the framecomprises an array of angled struts connected together by one or morepivot joints.

Clause 17. An assembly method for a prosthetic heart valve, the methodcomprising:

disposing tabs of adjacent leaflets together, each leaflet having a pairof tabs on opposite sides with respect to a centerline thereof;

providing a coupling member over exposed surface portions of the pair oftabs of the adjacent leaflets, the coupling member extending beyond endsof the tabs to form a collapsible pocket portion;

stitching together the coupling member and the tabs of the adjacentleaflets via a first suture spaced from the ends of the tabs to form acommissure tab assembly, the first suture being in a loose state;

inserting one or more external wedges between a surface of the pocketportion of the coupling member and the loose first suture;

conveying the commissure tab assembly and the one or more externalwedges through a closed window of a support member of an expandableframe of the prosthetic heart valve, the conveying being along a radialdirection of the expandable frame from a radially-inner side of theclosed window to a radially-outer side of the closed window; and

tightening the first suture such that the one or more external wedgesare arranged along the radial direction with the pair of tabs and thecoupling member therebetween, an effective width along a circumferentialdirection of the annular frame for a portion of the commissure tabassembly being increased by the one or more external wedges,

wherein a width along a circumferential direction of the one or moreexternal wedges and the pocket portion of the coupling member in acollapsed state is less than a width along the circumferential directionfor the closed window,

wherein the effective width for the portion of the commissure tabassembly is greater than a width along the circumferential direction fora corresponding portion of the closed window, and

wherein movement of the commissure tab assembly inward along the radialdirection is restrained by interaction of the portion of the commissuretab assembly with the corresponding portion of the closed window of thesupport member.

Clause 18. The method of clause 17, wherein the expandable frame of theprosthetic heart valve comprises an annular frame having an inflow endand an outflow end separated from the inflow end along an axialdirection of the frame, and/or the support member is coupled to theexpandable frame.

Clause 19. The method of any one of clauses 17-18, wherein theexpandable frame is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration.

Clause 20. The method of any one of clauses 17-19, wherein the one ormore external wedges comprise separate wedge members.

Clause 21. The method of any one of clauses 17-19, wherein the one ormore external wedges comprises a single-continuous wedge member.

Clause 22. The method of clause 21, wherein the single-continuous wedgemember is substantially U-shaped.

Clause 23. The method of any one of clauses 17-22, wherein the couplingmember comprises a cloth or fabric.

Clause 24. The method of any one of clauses 17-23, wherein each wedgecomprises a braided polymer suture or cable.

Clause 25. The method of any one of clauses 17-24, wherein each windowcomprises an opening or channel that extends through a thickness of thesupport member along the radial direction.

Clause 26. The method of any one of clauses 17-25, wherein each windowcomprises an opening or channel defined by a wireform coupled to thesupport member.

Clause 27. An assembly method for a prosthetic heart valve, the methodcomprising:

disposing tabs of adjacent leaflets together, each leaflet having a pairof tabs on opposite sides with respect to a centerline thereof;

providing a coupling member over exposed surface portions of the pair oftabs of the adjacent leaflets;

stitching together the tabs of the adjacent leaflets and the couplingmember via a first suture spaced from ends of the tabs;

disposing one or more external wedges in contact with first portions ofthe coupling member;

further stitching together the tabs, the coupling member, and the one ormore external wedges via a second suture to form a commissure tabassembly;

conveying the commissure tab assembly through a closed window of asupport member of an expandable frame of the prosthetic heart valve, theconveying being along a radial direction of the expandable frame from aradially-inner side of the closed window to a radially-outer side of theclosed window; and

inserting an internal wedge between the tabs of the commissure tabassembly at a first location along the radial direction between thefirst suture and the radially-outer side of the closed window, a widthalong a circumferential direction of the annular frame for a firstportion of the commissure tab assembly being increased by the wedge,

wherein the first suture is between the ends of the tabs and the secondsuture along the radial direction,

wherein the increased width first portion of the commissure tab assemblyis greater than a width along the circumferential direction for acorresponding portion of the radially-outer side of the closed window,

wherein movement of the commissure tab assembly inward along the radialdirection is restrained by interaction of the first portion of thecommissure tab assembly with the corresponding portion of the closedwindow of the support member

wherein a second portion of the commissure tab assembly, where the oneor more external wedges is disposed, has a width that is greater than awidth along the circumferential direction for a corresponding portion ofthe radially-inner side of the closed window, and

wherein movement of the commissure tab assembly outward along the radialdirection is restrained by interaction of the second portion of thecommissure tab assembly with the corresponding portion of the closedwindow of the support member.

Clause 28. The method of clause 27, wherein a length of the one or moreexternal wedges along an axial direction of the annular frame is greaterthan a length of the internal wedge along the axial direction.

Clause 29. The method of any one of clauses 27-28, wherein the disposingone or more external wedges includes wrapping each free end of thecoupling member around a respective one of the external wedges, and thesecond suture couples together each wrapped free end of the couplingmember, each external wedge, each first portion of the coupling member,and each leaflet tab.

Clause 30. The method of any one of clauses 27-29, wherein the ends ofthe leaflet tabs are disposed along the radial direction between the oneor more external wedges and the radially-outer side of the closedwindow.

Clause 31. The method of any one of clauses 27-30, wherein theexpandable frame of the prosthetic heart valve comprises an annularframe having an inflow end and an outflow end separated from the inflowend along an axial direction of the frame, and/or the support member iscoupled to the expandable frame.

Clause 32. The method of any one of clauses 27-31, wherein theexpandable frame is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration.

Clause 33. The method of any one of clauses 27-32, wherein the one ormore external wedges comprise separate wedge members.

Clause 34. The method of any one of clauses 27-32, wherein the one ormore external wedges comprises a single-continuous wedge member.

Clause 35. The method of clause 34, wherein the single-continuous wedgemember is substantially U-shaped.

Clause 36. The method of any one of clauses 27-35, wherein the couplingmember comprises a cloth or fabric.

Clause 37. The method of any one of clauses 27-36, wherein each wedgecomprises a braided polymer suture or cable.

Clause 38. The method of any one of clauses 27-37, wherein each windowcomprises an opening or channel that extends through a thickness of thesupport member along the radial direction.

Clause 39. The method of any one of clauses 27-38, wherein each windowcomprises an opening or channel defined by a wireform coupled to thesupport member.

Clause 40. An assembly method for a prosthetic heart valve, the methodcomprising:

disposing tabs of adjacent leaflets together, each leaflet having a pairof tabs on opposite sides with respect to a centerline thereof;

providing a coupling member over exposed surface portions of the pair oftabs of the adjacent leaflets, the coupling member extending beyond endsof the tabs to form a collapsible pocket portion;

disposing one or more external wedges in contact with first portions ofthe coupling member;

stitching together the tabs, the coupling member, and the one or moreexternal wedges via a first suture to form a commissure tab assembly;

conveying at least the collapsible pocket portion of the coupling memberthrough a closed window of a support member of an expandable annularframe of the prosthetic heart valve, the conveying being along a radialdirection of the expandable annular frame from a radially-inner side ofthe closed window to a radially-outer side of the closed window; and

expanding the pocket portion of the coupling member and inserting aninternal wedge into the expanded pocket portion at a first locationalong the radial direction between coupling member and theradially-outer side of the closed window,

wherein a combined width of the coupling member and the internal wedgealong a circumferential direction of the annular frame is greater than awidth along the circumferential direction for a corresponding portion ofthe radially-outer side of the closed window,

wherein movement of the commissure tab assembly inward along the radialdirection is restrained by interaction of the coupling member and theinternal wedge with the corresponding portion of the closed window ofthe support member,

wherein a portion of the commissure tab assembly, where the one or moreexternal wedges is disposed, has a width that is greater than a widthalong the circumferential direction for a corresponding portion of theradially-inner side of the closed window, and

wherein movement of the commissure tab assembly outward along the radialdirection is restrained by interaction of the portion of the commissuretab assembly with the corresponding portion of the closed window of thesupport member.

Clause 41. The method of clause 40, wherein a length of the one or moreexternal wedges along an axial direction of the annular frame is greaterthan a length of the internal wedge along the axial direction.

Clause 42. The method of any one of clauses 40-41, wherein the disposingone or more external wedges includes wrapping each free end of thecoupling member around a respective one of the external wedges, and thesecond suture couples together each wrapped free end of the couplingmember, each external wedge, each first portion of the coupling member,and each leaflet tab.

Clause 43. The method of any one of clauses 40-42, wherein the ends ofthe leaflet tabs are disposed along the radial direction between the oneor more external wedges and the radially-outer side of the closedwindow.

Clause 44. The method of any one of clauses 40-43, wherein theexpandable frame of the prosthetic heart valve comprises an annularframe having an inflow end and an outflow end separated from the inflowend along an axial direction of the frame, and/or the support member iscoupled to the expandable frame.

Clause 45. The method of any one of clauses 40-44, wherein theexpandable frame is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration.

Clause 46. The method of any one of clauses 40-45, wherein the one ormore external wedges comprise separate wedge members.

Clause 47. The method of any one of clauses 40-45, wherein the one ormore external wedges comprises a single-continuous wedge member.

Clause 48. The method of clause 47, wherein the single-continuous wedgemember is substantially U-shaped.

Clause 49. The method of any one of clauses 40-48, wherein the couplingmember comprises a cloth or fabric.

Clause 50. The method of any one of clauses 40-49, wherein each wedgecomprises a braided polymer suture or cable.

Clause 51. The method of any one of clauses 40-50, wherein each windowcomprises an opening or channel that extends through a thickness of thesupport member along the radial direction.

Clause 52. The method of any one of clauses 40-51, wherein each windowcomprises an opening or channel defined by a wireform coupled to thesupport member.

Clause 53. An assembly method for a prosthetic heart valve, the methodcomprising:

disposing tabs of adjacent leaflets together, each leaflet having a pairof tabs on opposite sides with respect to a centerline thereof;

disposing an internal wedge between facing surfaces of the tabs of theadjacent leaflets;

stitching together the tabs and the internal wedge via at least onefirst suture to form a commissure tab assembly;

stitching together the tabs via a second suture, the second suture beingdisposed between the internal wedge and ends of the tabs;

conveying a first portion of the commissure tab assembly into a windowof a support member of an expandable frame of the prosthetic heartvalve, the conveying being along an axial direction of the expandableframe from a proximal, open end of the window to a distal end of thewindow,

wherein, at a radial location corresponding to the internal wedge, thecommissure tab assembly has a second portion with an increased widthalong a circumferential direction of the expandable frame as compared tothe first portion,

wherein the increased width of the second portion is greater than awidth along the circumferential direction for a corresponding portion ofa radially-outer side of the window, and

wherein movement of the commissure tab assembly inward along a radialdirection of the frame is restrained by interaction of the secondportion of the commissure tab assembly with the corresponding portion ofthe window of the support member.

Clause 54. The method of clause 53, wherein the expandable frame of theprosthetic heart valve comprises an annular frame having an inflow endand an outflow end separated from the inflow end along the axialdirection of the frame, and/or the support member is coupled to theexpandable frame.

Clause 55. The method of any one of clauses 53-54, wherein theexpandable frame is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration.

Clause 56. The method of any one of clauses 53-55, further comprising:

prior to the stitching together the tabs and the internal wedge,disposing one or more external wedges on sides of the tabs opposite tothe internal wedge,

wherein the stitching together the tabs and the internal wedge includesstitching together the tabs, the internal wedge and the one or moreexternal wedges together via the at least one first suture.

Clause 57. The method of any one of clauses 53-56, wherein, after theconveying, the one or more external wedges are disposed along a radialdirection of the frame adjacent to or in contact with the support memberat the radially outer side of the window.

Clause 58. The method of any one of clauses 53-57, wherein:

the disposing tabs of adjacent leaflets comprises providing a couplingmember over surface portions of the pair of tabs of the adjacentleaflets,

the internal wedge is disposed between facing surfaces of the couplingmember and the facing surfaces of the tabs,

the stitching together the tabs and internal wedge comprises stitchingtogether the coupling member, the tabs, and the internal wedge via theat least one first suture, and

the stitching together the tabs comprises stitching together thecoupling member and the tabs via the second suture.

Clause 59. The method of any one of clauses 53-58, wherein the at leastone first suture is two first sutures, one of the tabs, the internalwedge, and one of the external wedges being coupled together by one ofthe first sutures, and the other of the tabs, the internal wedge, andthe other of the external wedges being coupled together by the other ofthe first sutures.

Clause 60. The method of any one of clauses 53-57, wherein:

the disposing tabs of adjacent leaflets comprises providing a couplingmember over surface portions of the pair of tabs of the adjacentleaflets,

the internal wedge is disposed between the facing surfaces of the tabswithout contacting the coupling member,

the stitching together the tabs and internal wedge comprises stitchingtogether the coupling member, the tabs, and the internal wedge via theat least one first suture, and

the stitching together the tabs comprises stitching together thecoupling member and the tabs via the second suture.

Clause 61. The method of any one of clauses 53-60, wherein the at leastone first suture is a single first suture that couples together thecoupling member, the tabs, and the internal wedge.

Clause 62. The method of any one of clauses 58-61, wherein:

after the conveying, free ends of the coupling member extend from theradially-inner side of the window,

the method further comprises wrapping each free end around an adjacentportion of the support member toward the radially-outer side of thewindow, and

the stitching together the tabs is after the conveying and comprisesstitching together the free ends, the tabs, and portions of the couplingmember between the free ends via the second suture.

Clause 63. The method of any one of clauses 58-61, wherein:

after the conveying, free ends of the coupling member are folded over toextend away from the radially-inner side of the window, and

the stitching together the tabs is after the conveying and comprisesstitching together the free ends, the tabs, and portions of the couplingmember between the free ends via the second suture.

Clause 64. The method of any one of clauses 58-61, wherein:

after the conveying, free ends of the coupling member are folded over toform pockets at the radially-inner side of the window and to extendthrough the window to the radially-outer side,

the method further comprises inserting one or more external wedges intothe pockets formed by the folded free ends, and

movement of the commissure tab assembly outward along a radial directionof the frame is further restrained by interaction of the one or moreexternal wedges with a corresponding portion of the window of thesupport member.

Clause 65. The method of any one of clauses 53-64, wherein the one ormore external wedges comprise separate wedge members.

Clause 66. The method of any one of clauses 53-64, wherein the one ormore external wedges comprises a single-continuous wedge member.

Clause 67. The method of clause 66, wherein the single-continuous wedgemember is substantially U-shaped.

Clause 68. The method of any one of clauses 53-67, wherein the couplingmember comprises a cloth or fabric.

Clause 69. The method of any one of clauses 53-68, wherein each wedgecomprises a braided polymer suture or cable.

Clause 70. The method of any one of clauses 53-69, wherein each windowcomprises an opening or channel that extends through a thickness of thesupport member along the radial direction.

Clause 71. The method of any one of clauses 53-70, wherein each windowcomprises an opening or channel defined by a wireform coupled to thesupport member.

Clause 72. An assembly method for a prosthetic heart valve, the methodcomprising:

disposing tabs of adjacent leaflets together, each leaflet having a pairof tabs on opposite sides with respect to a centerline thereof;

stitching together a coupling member and a wedge via a first suture;

disposing the coupling member over surface portions and between the pairof tabs of the adjacent leaflets such that the wedge is between facingsurfaces of the coupling member and between facing surfaces of the tabs;

stitching together the tabs and the coupling member via a second suture,the second suture being disposed between the wedge and ends of the tabsto form a commissure tab assembly;

conveying a first portion of the commissure tab assembly into a windowof a support member of an expandable frame of the prosthetic heartvalve, the conveying being along an axial direction of the expandableframe from a proximal, open end of the window to a distal end of thewindow,

wherein, at a radial location corresponding to the wedge, the commissuretab assembly has a second portion with an increased width along acircumferential direction of the annular frame as compared to the firstportion,

wherein the increased width of the second portion is greater than awidth along the circumferential direction for a corresponding portion ofa radially-outer side of the window, and

wherein movement of the commissure tab assembly inward along a radialdirection of the frame is restrained by interaction of the secondportion of the commissure tab assembly with the corresponding portion ofthe window of the support member.

Clause 73. The method of clause 72, wherein the expandable frame of theprosthetic heart valve comprises an annular frame having an inflow endand an outflow end separated from the inflow end along the axialdirection of the frame, and/or the support member is coupled to theexpandable frame.

Clause 74. The method of any one of clauses 72-73, wherein theexpandable frame is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration.

Clause 75. The method of any one of clauses 72-74, wherein:

after the conveying, free ends of the coupling member extend from aradially-inner side of the window,

the method further comprises wrapping each free end around an adjacentportion of the support member toward the radially-outer side of thewindow, and

the stitching together the tabs is after the conveying and comprisesstitching together the free ends, the tabs, and portions of the couplingmember between the free ends via the second suture.

Clause 76. The method of any one of clauses 72-74, wherein:

after the conveying, free ends of the coupling member are folded over toextend away from a radially-inner side of the window, and

the stitching together the tabs is after the conveying and comprisesstitching together the free ends, the tabs, and portions of the couplingmember between the free ends via the second suture.

Clause 77. The method of any one of clauses 72-74, wherein:

after the conveying, free ends of the coupling member are folded over toform pockets at a radially-inner side of the window and to extendthrough the window to the radially-outer side,

the method further comprises inserting one or more external wedges intothe pockets formed by the folded free ends, and

movement of the commissure tab assembly outward along a radial directionof the frame is further restrained by interaction of the one or moreexternal wedges with a corresponding portion of the window of thesupport member.

Clause 78. The method of any one of clauses 72-77, wherein the one ormore external wedges comprise separate wedge members.

Clause 79. The method of any one of clauses 72-77, wherein the one ormore external wedges comprises a single-continuous wedge member.

Clause 80. The method of clause 79, wherein the single-continuous wedgemember is substantially U-shaped.

Clause 81. The method of any one of clauses 72-80, wherein the couplingmember comprises a cloth or fabric.

Clause 82. The method of any one of clauses 72-81, wherein each wedgecomprises a braided polymer suture or cable.

Clause 83. The method of any one of clauses 72-82, wherein each windowcomprises an opening or channel that extends through a thickness of thesupport member along the radial direction.

Clause 84. The method of any one of clauses 72-83, wherein each windowcomprises an opening or channel defined by a wireform coupled to thesupport member.

Clause 85. An assembly method for a prosthetic heart valve, the methodcomprising:

disposing tabs of adjacent leaflets together, each leaflet having a pairof tabs on opposite sides with respect to a centerline thereof;

disposing one or more external wedges adjacent to external surfaces ofthe tabs of the adjacent leaflets;

stitching together the tabs and the one or more external wedges via atleast one first suture to form a commissure tab assembly;

conveying a first portion of the commissure tab assembly into a windowof a support member of an expandable frame of the prosthetic heartvalve, the conveying being along an axial direction of the expandableframe from a proximal, open end of the window to a distal end of thewindow,

wherein, at a radial location corresponding to the one or more externalwedges, the commissure tab assembly has a second portion with anincreased width along a circumferential direction of the annular frameas compared to the first portion,

wherein the increased width of the second portion is greater than awidth along the circumferential direction for a corresponding portion ofa radially-outer side of the window, and

wherein movement of the commissure tab assembly inward along a radialdirection of the frame is restrained by interaction of the secondportion of the commissure tab assembly with the corresponding portion ofthe window of the support member.

Clause 86. The method of clause 85, wherein the expandable frame of theprosthetic heart valve comprises an annular frame having an inflow endand an outflow end separated from the inflow end along the axialdirection of the frame, and/or the support member is coupled to theexpandable frame.

Clause 87. The method of any one of clauses 85-86, wherein theexpandable frame is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration.

Clause 88. The method of any one of clauses 85-87, wherein:

the disposing tabs of adjacent leaflets comprises providing a couplingmember over the pair of tabs of the adjacent leaflets,

the one or more external wedges are disposed on exposed surface portionsof the coupling member, and

the stitching together the tabs and the one or more external wedgescomprises stitching together the coupling member, the tabs, and the oneor more external wedges via the at least one first suture.

Clause 89. The method of any one of clauses 85-88, wherein after theconveying, free ends of the coupling member extend from theradially-inner side of the window, and the method further comprises:

wrapping each free end around an adjacent portion of the support membertoward the radially-outer side of the window; and

stitching together the free ends, the tabs, and portions of the couplingmember between the free ends via a second suture.

Clause 90. The method of any one of clauses 85-89, wherein the one ormore external wedges comprise separate wedge members.

Clause 91. The method of any one of clauses 85-89, wherein the one ormore external wedges comprises a single-continuous wedge member.

Clause 92. The method of clause 91, wherein the single-continuous wedgemember is substantially U-shaped.

Clause 93. The method of any one of clauses 85-92, wherein the couplingmember comprises a cloth or fabric.

Clause 94. The method of any one of clauses 85-93, wherein each wedgecomprises a braided polymer suture or cable.

Clause 95. The method of any one of clauses 85-94, wherein each windowcomprises an opening or channel that extends through a thickness of thesupport member along the radial direction.

Clause 96. The method of any one of clauses 85-95, wherein each windowcomprises an opening or channel defined by a wireform coupled to thesupport member.

Clause 97. An assembly method for a prosthetic heart valve, the methodcomprising:

overlapping a first tab of a first leaflet with a second tab of anadjacent second leaflet, each leaflet having a pair of tabs on oppositesides with respect to a centerline thereof;

disposing a first wedge on an exposed surface of the second tab in aregion where the second tab overlaps with the first tab;

disposing a second wedge on an exposed surface of the first tab in aregion where the second tab overlaps with the first tab;

stitching together the first and second tabs and the first and secondwedges via a first suture;

wrapping the first and second tabs around the first wedge to form acommissure tab assembly, the wrapping being such that remaining portionsof the first and second leaflets extend in a common direction and suchthat a pocket is formed by the wrapped first and second tabs enclosingthe first wedge; and

conveying a first portion of the commissure tab assembly into a windowof a support member of an expandable frame of the prosthetic heartvalve, the conveying being along an axial direction of the expandableframe from a proximal, open end of the window to a distal end of thewindow,

wherein, at a radial location corresponding to the first wedge, thecommissure tab assembly has a second portion with an increased widthalong a circumferential direction of the frame as compared to the firstportion,

wherein the increased width of the second portion is greater than awidth along the circumferential direction for a corresponding portion ofa radially-outer side of the window, and

wherein movement of the commissure tab assembly inward along a radialdirection of the frame is restrained by interaction of the secondportion of the commissure tab assembly with the corresponding portion ofthe window of the support member.

Clause 98. The method of clause 97, wherein the expandable frame of theprosthetic heart valve comprises an annular frame having an inflow endand an outflow end separated from the inflow end along the axialdirection of the frame, and/or the support member is coupled to theexpandable frame.

Clause 99. The method of any one of clauses 97-98, wherein theexpandable frame is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration.

Clause 100. The method of any one of clauses 97-99, wherein a diameterof the first wedge is greater than a diameter of the second wedge, alength of the first wedge is less than a length of the second wedge, anda length of the first wedge is less than a height of the first tab orthe second tab.

Clause 101. The method of any one of clauses 97-100, wherein the secondwedge has free ends that extend beyond top and bottom edges of the firsttab.

Clause 102. The method of any one of clauses 97-101, the methodcomprising inserting the free ends of the second wedge intocorresponding end portions of the first wedge.

Clause 103. The method of any one of clauses 97-102, the methodcomprising disposing the free ends of the second wedge adjacent to thefirst wedge in the pocket formed by the wrapped tabs.

Clause 104. The method of any one of clauses 97-103, wherein the one ormore external wedges comprise separate wedge members.

Clause 105. The method of any one of clauses 97-103, wherein the one ormore external wedges comprises a single-continuous wedge member.

Clause 106. The method of clause 105, wherein the single-continuouswedge member is substantially U-shaped.

Clause 107. The method of any one of clauses 97-106, wherein thecoupling member comprises a cloth or fabric.

Clause 108. The method of any one of clauses 97-107, wherein each wedgecomprises a braided polymer suture or cable.

Clause 109. The method of any one of clauses 97-108, wherein each windowcomprises an opening or channel that extends through a thickness of thesupport member along the radial direction.

Clause 110. The method of any one of clauses 97-109, wherein each windowcomprises an opening or channel defined by a wireform coupled to thesupport member.

Clause 111. An assembly method for a prosthetic heart valve, the methodcomprising:

disposing tabs of adjacent leaflets together, each leaflet having a pairof tabs on opposite sides with respect to a centerline thereof;

disposing one or more external wedges adjacent to external surfaces ofthe tabs of the adjacent leaflets;

stitching together the tabs and the one or more external wedges via atleast one first suture;

wrapping a free end portion of each tab around a respective one of theexternal wedges to form a commissure tab assembly, the wrapping beingsuch that the free end portions of the tabs and remaining portions ofthe leaflets extend in a common direction and such that pockets areformed by the wrapped free end portions enclosing the external wedges;and

conveying a first portion of the commissure tab assembly into a windowof a support member of an expandable frame of the prosthetic heartvalve, the conveying being along an axial direction of the expandableframe from a proximal, open end of the window to a distal end of thewindow,

wherein, at a radial location corresponding to the one or more externalwedges, the commissure tab assembly has a second portion with anincreased width along a circumferential direction of the annular frameas compared to the first portion,

wherein the increased width of the second portion is greater than awidth along the circumferential direction for a corresponding portion ofa radially-outer side of the window, and

wherein movement of the commissure tab assembly inward along a radialdirection of the frame is restrained by interaction of the secondportion of the commissure tab assembly with the corresponding portion ofthe window of the support member.

Clause 112. The method of clause 111, wherein the expandable frame ofthe prosthetic heart valve comprises an annular frame having an inflowend and an outflow end separated from the inflow end along the axialdirection of the frame, and/or the support member is coupled to theexpandable frame.

Clause 113. The method of any one of clauses 111-112, wherein theexpandable frame is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration.

Clause 114. The method of any one of clauses 111-113, wherein eachwrapped free end portion extends from the radially-outer side of thewindow toward the radially-inner side of the window.

Clause 115. The method of any one of clauses 111-114, wherein arespective end of each free end portion is disposed along the radialdirection adjacent to the radially-inner side of the window.

Clause 116. The method of any one of clauses 111-115, wherein athickness of the first portion of the commissure tab assembly is aboutfour times a thickness of each leaflet tab.

Clause 117. The method of any one of clauses 111-116, wherein:

the disposing tabs of adjacent leaflets comprises providing one or morecoupling members over surface portions of the pair of tabs of theadjacent leaflets, each coupling member being on an opposite side of therespective tab from the one or more external wedges,

the stitching together the tabs and internal wedge comprises stitchingtogether each coupling member, the tabs, and each external wedge via theat least one first suture, and

the wrapping includes wrapping free end portions of each tab andcoupling member around a respective one of the external wedges to form acommissure tab assembly.

Clause 118. The method of any one of clauses 111-117, wherein:

the at least one first suture is two first sutures and the one or morecoupling members is two coupling members, and

one of the tabs, one of the coupling members, and one of the externalwedges being coupled together by one of the first sutures, and the otherof the tabs, the other of the coupling members, and the other of theexternal wedges being coupled together by the other of the firstsutures.

Clause 119. The method of clause 118, wherein the portion of eachcoupling members stitched by the first sutures comprises a folded-over,double-thickness portion of the respective coupling member.

Clause 120. The method of any one of clauses 111-119, wherein:

after the conveying, free ends of the one or more coupling membersextend from the radially-inner side of the window,

the method comprises wrapping each free end around an adjacent portionof the support member toward the radially-outer side of the window, and

the method comprises stitching the free ends of the one or more couplingmembers to the second portion of the commissure tab assembly.

Clause 121. The method of any one of clauses 111-120, wherein the one ormore external wedges comprise separate wedge members.

Clause 122. The method of any one of clauses 111-120, wherein the one ormore external wedges comprises a single-continuous wedge member.

Clause 123. The method of clause 122, wherein the single-continuouswedge member is substantially U-shaped.

Clause 124. The method of any one of clauses 111-123, wherein thecoupling member comprises a cloth or fabric.

Clause 125. The method of any one of clauses 111-124, wherein each wedgecomprises a braided polymer suture or cable.

Clause 126. The method of any one of clauses 111-125, wherein eachwindow comprises an opening or channel that extends through a thicknessof the support member along the radial direction.

Clause 127. The method of any one of clauses 111-126, wherein eachwindow comprises an opening or channel defined by a wireform coupled tothe support member.

Clause 128. The method of any one of clauses 1-127, wherein the valvularstructure is a bicuspid structure with two leaflets and two commissuretab assemblies, and the commissure support posts are on diametricallyopposite sides of the frame from each other.

Clause 129. The method of any one of clauses 1-127, wherein the valvularstructure is a tricuspid structure with three leaflets and threecommissure tab assemblies, and the commissure support posts are equallyspaced around a circumference of the frame.

Clause 130. The method of any one of clauses 1-129, wherein the frame isformed of a plastically-expandable material or a self-expandingmaterial.

Clause 131. The method of any one of clauses 1-129, wherein the framecomprises an array of angled struts connected together by one or morepivot joints.

Clause 132. A prosthetic heart valve, comprising:

a frame that is radially collapsible and expandable between aradially-compressed configuration and a radially-expanded configuration,the frame having an inflow end and an outflow end separated from theinflow end along an axial direction of the frame, the frame comprising aplurality of support posts; and

a valvular structure supported within the annular frame and comprising aplurality of leaflets, each leaflet having a pair of tabs, the tabs ofadjacent leaflets being coupled together to form a commissure tabassembly,

wherein there is one support post for each commissure tab assembly, and

each commissure tab assembly is coupled to the respective support postaccording to the method of any of clauses 1-131.

Clause 133. The prosthetic heart valve of clause 132, wherein thesupport posts comprise portions of actuator or locking mechanisms of theframe.

Clause 134. The prosthetic heart valve of clause 132, wherein thesupport posts are coupled to actuator or locking mechanisms of theannular frame.

Clause 135. The prosthetic heart valve of any one of clauses 132-134,wherein the valvular structure is a bicuspid structure with two leafletsand two commissure tab assemblies, and the valvular structure is coupledto the frame via the commissure tab assemblies on diametrically oppositesides of the frame from each other.

Clause 136. The prosthetic heart valve of any one of clauses 132-134,wherein the valvular structure is a tricuspid structure with threeleaflets and three commissure tab assemblies, and the valvular structureis coupled to the frame via the three commissure tab assemblies equallyspaced along the circumferential direction of the frame.

Clause 137 The prosthetic heart valve of any one of clauses 132-136,wherein the frame comprises an annular frame.

Clause 138. The prosthetic heart valve of any one of clauses 132-137,wherein the frame is formed of a plastically-expandable material or aself-expanding material.

Clause 139. The prosthetic heart valve of any one of clauses 132-137,wherein the annular frame comprises an array of angled struts connectedtogether by one or more pivot joints.

Clause 140. The prosthetic heart valve of any one of clauses 132-139,wherein the prosthetic heart valve is constructed for implantation in anexisting heart valve within a patient.

Clause 141. The prosthetic heart valve of any one of clauses 132-140,wherein the prosthetic heart valve is constructed for implantation at anaortic position or a mitral position.

Clause 142. An assembly, comprising:

a delivery apparatus comprising an elongated shaft; and

the prosthetic heart valve of any one of clauses 132-140 mounted on theelongated shaft in the radially-compressed configuration for deliveryinto a patient's body.

Clause 143. A method of implanting a prosthetic heart valve in apatient's body, the method comprising:

inserting a distal end of a delivery apparatus into vasculature of apatient, the delivery apparatus comprising an elongated shaft, theprosthetic heart valve of any one of clauses 132-140 being releasablymounted in the radially-compressed configuration on the elongated shaftof the delivery apparatus;

advancing the prosthetic heart valve to a desired implantation site; and

using the delivery apparatus to expand the prosthetic heart valve to theradially-expanded configuration, thereby implanting the prosthetic heartvalve at the desired implantation site.

Clause 144. A method of implanting a prosthetic heart valve in apatient's body, the method comprising:

inserting a distal end of a delivery apparatus into vasculature of apatient, the delivery apparatus comprising an elongated shaft, theprosthetic heart valve of any one of clauses 132-140 being releasablymounted in the radially-compressed configuration on the elongated shaftof the delivery apparatus;

advancing the prosthetic heart valve to a desired implantation site; and

deploying the prosthetic heart valve from the delivery apparatus suchthat the prosthetic heart valve self-expands to the radially-expandedconfiguration, thereby implanting the prosthetic heart valve at thedesired implantation site.

Clause 145. The method of any one of clauses 143-144, wherein theadvancing to the desired implantation site employs transfemoral,transventricular, transapical, or transseptal approaches.

GENERAL CONSIDERATIONS

All features described herein are independent of one another and, exceptwhere structurally impossible, can be used in combination with any otherfeature described herein. For example, the wire form configurationillustrated in FIGS. 20A-20E can be used in place of any of the open orclosed window configurations described with respect to FIGS. 5A-19D.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatus, and systems should not be construed asbeing limiting in any way. Instead, the present disclosure is directedtoward all novel and nonobvious features and aspects of the variousdisclosed embodiments, alone and in various combinations andsub-combinations with one another. The methods, apparatus, and systemsare not limited to any specific aspect or feature or combinationthereof, nor do the disclosed embodiments require that any one or morespecific advantages be present, or problems be solved. The technologiesfrom any example can be combined with the technologies described in anyone or more of the other examples.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage set forth below. For example, operations described sequentiallymay in some cases be rearranged or performed concurrently. Moreover, forthe sake of simplicity, the attached figures may not show the variousways in which the disclosed methods can be used in conjunction withother methods. Additionally, the description sometimes uses terms like“provide” or “achieve” to describe the disclosed methods. These termsare high-level abstractions of the actual operations that are performed.The actual operations that correspond to these terms may vary dependingon the particular implementation and are readily discernible by one ofordinary skill in the art.

As used herein with reference to the prosthetic heart valve assembly andimplantation and structures of the prosthetic heart valve, “proximal”refers to a position, direction, or portion of a component that iscloser to the user and a handle of the delivery system or apparatus thatis outside the patient, while “distal” refers to a position, direction,or portion of a component that is further away from the user and thehandle, and closer to the implantation site. The terms “longitudinal”and “axial” refer to an axis extending in the proximal and distaldirections, unless otherwise expressly defined.

The terms “axial direction,” “radial direction,” and “circumferentialdirection” have been used herein to describe the arrangement andassembly of components relative to the geometry of the frame of theprosthetic heart valve. Such terms have been used for convenientdescription, but the disclosed embodiments are not strictly limited tothe description. In particular, where a component or action is describedrelative to a particular direction, directions parallel to the specifieddirection as well as minor deviations therefrom are included. Thus, adescription of a component extending along an axial direction of theframe does not require the component to be aligned with a center of theframe; rather, the component can extend substantially along a directionparallel to a central axis of the frame.

As used herein, the terms “integrally formed” and “unitary construction”refer to a construction that does not include any welds, fasteners, orother means for securing separately formed pieces of material to eachother.

As used herein, operations that occur “simultaneously” or “concurrently”occur generally at the same time as one another, although delays in theoccurrence of operation relative to the other due to, for example,spacing between components, are expressly within the scope of the aboveterms, absent specific contrary language.

As used in this application and in the claims, the singular forms “a,”“an,” and “the” include the plural forms unless the context clearlydictates otherwise. Additionally, the term “includes” means “comprises.”Further, the term “coupled” generally means physically, mechanically,chemically, magnetically, and/or electrically coupled or linked and doesnot exclude the presence of intermediate elements between the coupled orassociated items absent specific contrary language. As used herein,“and/or” means “and” or “or,” as well as “and” and “or.”

Directions and other relative references may be used to facilitatediscussion of the drawings and principles herein, but are not intendedto be limiting. For example, certain terms may be used such as “inner,”“outer,” “upper,” “lower,” “inside,” “outside,”, “top,” “bottom,”“interior,” “exterior,” “left,” “right,” and the like. Such terms areused, where applicable, to provide some clarity of description whendealing with relative relationships, particularly with respect to theillustrated examples. Such terms are not, however, intended to implyabsolute relationships, positions, and/or orientations. For example,with respect to an object, an “upper” part can become a “lower” partsimply by turning the object over. Nevertheless, it is still the samepart and the object remains the same.

In view of the many possible embodiments to which the principles of thedisclosed technology may be applied, it should be recognized that theillustrated examples are only preferred examples and should not be takenas limiting the scope of the disclosed technology. Rather, the scope ofthe disclosed technology is defined by the following claims. Wetherefore claim all that comes within the scope of these claims.

1. An assembly method for a prosthetic heart valve, the method comprising: disposing tabs of adjacent leaflets together, each leaflet having a pair of tabs on opposite sides with respect to a centerline thereof; stitching together the tabs of the adjacent leaflets via a first suture spaced from ends of the tabs to form a commissure tab assembly; conveying the commissure tab assembly through a closed window of a support member of an expandable annular frame of the prosthetic heart valve, the conveying being along a radial direction of the expandable annular frame from a radially-inner side of the closed window to a radially-outer side of the closed window; and inserting a wedge between the tabs of the commissure tab assembly at a first location along the radial direction between the first suture and the radially-outer side of the closed window, a width along a circumferential direction of the annular frame for a portion of the commissure tab assembly being increased by the wedge.
 2. The method of claim 1, wherein: the disposing tabs of adjacent leaflets comprises providing a coupling member over exposed surface portions of the pair of tabs of the adjacent leaflets; and the stitching comprises stitching together the coupling member and the tabs of the adjacent leaflets via the first suture to form the commissure tab assembly.
 3. The method of claim 2, wherein: the providing the coupling member is such that a portion of the coupling member is arranged between facing surfaces of the pair of tabs so as to form a collapsed pocket portion; and the inserting the wedge comprises expanding the pocket portion and disposing the wedge therein.
 4. The method of claim 3, wherein, after the conveying, free ends of the coupling member extend from the radially-inner side of the closed window, the method further comprising: wrapping each free end around an adjacent portion of the support member toward the radially-outer side of the closed window; and stitching together the free ends and the commissure tab assembly via a second suture spaced from the ends of the tabs, wherein the first suture is between the wedge and the second suture along the radial direction.
 5. The method of claim 4, wherein: after the inserting, one or more ends of the wedge extend axially above or below the commissure tab assembly, and the method further comprises inserting the one or more ends of the wedge between the tabs of the commissure tab assembly at a second location along the radial direction between the first location and the ends of the tabs.
 6. The method of claim 5, wherein the second location is between the first suture and the second suture along the radial direction.
 7. The method of claim 1, wherein the increased width of the commissure tab assembly portion is greater than a width along the circumferential direction for a corresponding portion of the radially-outer side of the closed window.
 8. The method of claim 1, wherein movement of the commissure tab assembly inward along the radial direction is restrained by interaction of the increased width portion of the commissure tab assembly with the corresponding portion of the closed window of the support member.
 9. An assembly method for a prosthetic heart valve, the method comprising: disposing tabs of adjacent leaflets together, each leaflet having a pair of tabs on opposite sides with respect to a centerline thereof; disposing one or more external wedges adjacent to external surfaces of the tabs of the adjacent leaflets; stitching together the tabs and the one or more external wedges via at least one first suture; wrapping a free end portion of each tab around a respective one of the external wedges to form a commissure tab assembly, the wrapping being such that the free end portions of the tabs and remaining portions of the leaflets extend in a common direction and such that pockets are formed by the wrapped free end portions enclosing the external wedges; and conveying a first portion of the commissure tab assembly into a window of a support member of an expandable annular frame of the prosthetic heart valve, the conveying being along an axial direction of the expandable annular frame from a proximal, open end of the window to a distal end of the window.
 10. The method of claim 9, wherein, at a radial location corresponding to the one or more external wedges, the commissure tab assembly has a second portion with an increased width along a circumferential direction of the annular frame as compared to the first portion.
 11. The method of claim 9, wherein the increased width of the second portion is greater than a width along the circumferential direction for a corresponding portion of a radially-outer side of the window.
 12. The method of claim 9, wherein movement of the commissure tab assembly inward along a radial direction of the frame is restrained by interaction of the second portion of the commissure tab assembly with the corresponding portion of the window of the support member.
 13. The method of claim 9, wherein each wrapped free end portion extends from the radially-outer side of the window toward a radially-inner side of the window.
 14. The method of claim 13, wherein a respective end of each free end portion is disposed along a radial direction of the frame adjacent to the radially-inner side of the window.
 15. The method of claim 14, wherein: the disposing tabs of adjacent leaflets comprises providing one or more coupling members over surface portions of the pair of tabs of the adjacent leaflets, each coupling member being on an opposite side of the respective tab from the one or more external wedges, the stitching together the tabs and internal wedge comprises stitching together each coupling member, the tabs, and each external wedge via the at least one first suture, and the wrapping includes wrapping free end portions of each tab and coupling member around a respective one of the external wedges to form a commissure tab assembly.
 16. The method of claim 15, wherein: the at least one first suture is two first sutures and the one or more coupling members is two coupling members, and one of the tabs, one of the coupling members, and one of the external wedges being coupled together by one of the first sutures, and the other of the tabs, the other of the coupling members, and the other of the external wedges being coupled together by the other of the first sutures.
 17. The method of claim 16, wherein: after the conveying, free ends of the one or more coupling members extend from the radially-inner side of the window, the method comprises wrapping each free end around an adjacent portion of the support member toward the radially-outer side of the window, and the method comprises stitching the free ends of the one or more coupling members to the second portion of the commissure tab assembly.
 18. The method of claim 9, wherein the one or more external wedges comprises a single continuous wedge member that is substantially U-shaped.
 19. The method of claim 9, wherein the coupling member comprises a cloth or fabric, or each wedge comprises a braided polymer suture or cable.
 20. The method of claim 9, wherein each window comprises an opening or channel that extends through a thickness of the support member along the radial direction, or each window comprises an opening or channel defined by a wireform coupled to the support member. 